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Paclitaxel, Polyglutamate Paclitaxel, or Observation in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Peritoneal Cancer, or Fallopian Tube Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00108745
Recruitment Status : Active, not recruiting
First Posted : April 19, 2005
Results First Posted : April 1, 2021
Last Update Posted : September 30, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
GOG Foundation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Fallopian Tube Clear Cell Adenocarcinoma
Fallopian Tube Endometrioid Adenocarcinoma
Fallopian Tube Mucinous Adenocarcinoma
Fallopian Tube Serous Adenocarcinoma
Fallopian Tube Transitional Cell Carcinoma
Fallopian Tube Undifferentiated Carcinoma
Ovarian Brenner Tumor
Ovarian Clear Cell Adenocarcinoma
Ovarian Endometrioid Adenocarcinoma
Ovarian Mucinous Adenocarcinoma
Ovarian Seromucinous Carcinoma
Ovarian Serous Adenocarcinoma
Ovarian Transitional Cell Carcinoma
Ovarian Undifferentiated Carcinoma
Primary Peritoneal Serous Adenocarcinoma
Stage IIIA Fallopian Tube Cancer AJCC v7
Stage IIIA Ovarian Cancer AJCC v6 and v7
Stage IIIA Primary Peritoneal Cancer AJCC v7
Stage IIIB Fallopian Tube Cancer AJCC v7
Stage IIIB Ovarian Cancer AJCC v6 and v7
Stage IIIB Primary Peritoneal Cancer AJCC v7
Stage IIIC Fallopian Tube Cancer AJCC v7
Stage IIIC Ovarian Cancer AJCC v6 and v7
Stage IIIC Primary Peritoneal Cancer AJCC v7
Stage IV Fallopian Tube Cancer AJCC v6 and v7
Stage IV Ovarian Cancer AJCC v6 and v7
Stage IV Primary Peritoneal Cancer AJCC v7
Interventions Other: Clinical Observation
Other: Laboratory Biomarker Analysis
Drug: Paclitaxel
Drug: Paclitaxel Poliglumex
Procedure: Quality-of-Life Assessment
Enrollment 1157
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (Paclitaxel Poliglumex) Arm II (Paclitaxel) Arm III (Observation)
Hide Arm/Group Description

Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel Poliglumex: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive no further anticancer treatment until evidence of disease progression.

Clinical Observation: Undergo observation

Laboratory Biomarker Analysis: Correlative studies

Quality-of-Life Assessment: Ancillary studies
Period Title: Overall Study
Started 387 384 386
Completed 353 349 349
Not Completed 34 35 37
Reason Not Completed
Withdrawal by Subject             19             12             12
Never Treated             8             10             12
Ineligible             7             13             13
Arm/Group Title Arm I (Paclitaxel Poliglumex) Arm II (Paclitaxel) Arm III (Observation) Total
Hide Arm/Group Description

Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel Poliglumex: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive no further anticancer treatment until evidence of disease progression.

Clinical Observation: Undergo observation

Laboratory Biomarker Analysis: Correlative studies

Quality-of-Life Assessment: Ancillary studies

 Total of all reporting groups
Overall Number of Baseline Participants 387 384 386 1157
Hide Baseline Analysis Population Description
All enrolled patients.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 387 participants 384 participants 386 participants 1157 participants
59.02  (10.89) 58.80  (10.42) 59.07  (9.68) 58.96  (10.34)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 387 participants 384 participants 386 participants 1157 participants
< 40 years
21
   5.4%
13
   3.4%
11
   2.8%
45
   3.9%
40 - 49 years
54
  14.0%
71
  18.5%
57
  14.8%
182
  15.7%
50 - 59 years
115
  29.7%
114
  29.7%
138
  35.8%
367
  31.7%
60 - 69 years
137
  35.4%
132
  34.4%
126
  32.6%
395
  34.1%
70 - 79 years
56
  14.5%
46
  12.0%
49
  12.7%
151
  13.1%
>= 80 years
4
   1.0%
8
   2.1%
5
   1.3%
17
   1.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 387 participants 384 participants 386 participants 1157 participants
Female
387
 100.0%
384
 100.0%
386
 100.0%
1157
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 387 participants 384 participants 386 participants 1157 participants
Hispanic or Latino
18
   4.7%
25
   6.5%
16
   4.1%
59
   5.1%
Not Hispanic or Latino
341
  88.1%
338
  88.0%
346
  89.6%
1025
  88.6%
Unknown or Not Reported
28
   7.2%
21
   5.5%
24
   6.2%
73
   6.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 387 participants 384 participants 386 participants 1157 participants
American Indian or Alaska Native
1
   0.3%
3
   0.8%
1
   0.3%
5
   0.4%
Asian
7
   1.8%
11
   2.9%
9
   2.3%
27
   2.3%
Native Hawaiian or Other Pacific Islander
1
   0.3%
1
   0.3%
1
   0.3%
3
   0.3%
Black or African American
21
   5.4%
13
   3.4%
17
   4.4%
51
   4.4%
White
353
  91.2%
352
  91.7%
355
  92.0%
1060
  91.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
   1.0%
4
   1.0%
3
   0.8%
11
   1.0%
1.Primary Outcome
Title Overall Survival
Hide Description Overall survival (OS) was defined as the number of months between study enrollment and death from any cause. Patients still alive at the last follow-up were censored on the date of last contact.
Time Frame All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next five years.
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized
Arm/Group Title Arm I (Paclitaxel Poliglumex) Arm II (Paclitaxel) Arm III (Observation)
Hide Arm/Group Description:

Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel Poliglumex: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive no further anticancer treatment until evidence of disease progression.

Clinical Observation: Undergo observation

Laboratory Biomarker Analysis: Correlative studies

Quality-of-Life Assessment: Ancillary studies
Overall Number of Participants Analyzed 387 384 386
Median (95% Confidence Interval)
Unit of Measure: Months
60.0
(51.7 to 68.6)
56.8
(47.3 to 65.9)
58.3
(51.9 to 72.5)
2.Secondary Outcome
Title Progression-free Survival
Hide Description Progression free survival (PFS) was defined as the number of months between study enrollment and the date of first clinical, biochemical, or radiological evidence of progression or death due to any cause. Patients who were alive without progression at the time of analysis were censored on the date of the last tumor assessment.
Time Frame Progression was assessed every 8 weeks for the first 15 months, then every 3 months, up to 14.2 years.
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized
Arm/Group Title Arm I (Paclitaxel Poliglumex) Arm II (Paclitaxel) Arm III (Observation)
Hide Arm/Group Description:

Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel Poliglumex: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive no further anticancer treatment until evidence of disease progression.

Clinical Observation: Undergo observation

Laboratory Biomarker Analysis: Correlative studies

Quality-of-Life Assessment: Ancillary studies
Overall Number of Participants Analyzed 387 384 386
Median (95% Confidence Interval)
Unit of Measure: Months
16.3
(14.4 to 18.9)
18.9
(17.0 to 21.8)
13.4
(11.2 to 15.7)
3.Secondary Outcome
Title Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0
Hide Description Number of treated patients with Adverse Events (grade 3 or higher) observed while receiving randomized therapy among adverse event terms with at least 4 patients reporting.
Time Frame Measured within 6 months of enrollment; through all cycles of chemotherapy and up to 30 days after the last cycle of chemotherapy. Up to 10 cycles of chemotherapy were allowed. Cycles were to be repeated every 3 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Treated with randomized therapy
Arm/Group Title Arm I (Paclitaxel Poliglumex) Arm II (Paclitaxel) Arm III (Observation)
Hide Arm/Group Description:

Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel Poliglumex: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive no further anticancer treatment until evidence of disease progression.

Clinical Observation: Undergo observation

Laboratory Biomarker Analysis: Correlative studies

Quality-of-Life Assessment: Ancillary studies
Overall Number of Participants Analyzed 379 374 386
Measure Type: Number
Unit of Measure: participants
Allergic Reaction / Hypersensitivity 4 0 0
Dehydration 4 1 1
Diarrhea 7 3 2
Dyspnea 2 4 2
Fatigue 6 13 1
Hemoglobin 8 2 0
Hyperglycemia 5 6 1
Hypertension 2 4 5
Hypokalemia 9 2 0
Leukocytes 36 17 1
Nausea 7 3 4
Neuropathy-Motor 3 8 1
Neutrophils 82 62 2
Obstruction, GI - Small Bowel Nos 5 6 9
Pain: Abdominal Pain Nos 12 5 5
Pain: Back 7 4 1
Pain: Extremity-Limb 1 7 0
Pain: Head/Headache 4 2 0
Pain: Joint 5 3 1
Thrombosis / Thrombus / Embolism 5 4 2
Vomiting 8 6 3
4.Secondary Outcome
Title Patient-Reported Quality of Life (QOL)
Hide Description Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for ovarian cancer (FACT-O TOI). The FACT-En TOI is a scale for assessing general QOL of ovarian cancer patients. The FACT-O TOI score ranges 0-100 with a large score suggesting better QOL.
Time Frame 1. Prior to treatment 2. Prior to cycle 3 3. Prior to cycle 5 4. Prior to cycle 7 5. Prior to cycle 12 6. 12 months post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Provided baseline and >= 1 follow-up assessment
Arm/Group Title Arm I (Paclitaxel Poliglumex) Arm II (Paclitaxel) Arm III (Observation)
Hide Arm/Group Description:

Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel Poliglumex: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive no further anticancer treatment until evidence of disease progression.

Clinical Observation: Undergo observation

Laboratory Biomarker Analysis: Correlative studies

Quality-of-Life Assessment: Ancillary studies
Overall Number of Participants Analyzed 374 366 373
Mean (Standard Error)
Unit of Measure: score on a scale
Baseline 78.2  (0.6) 77.3  (0.7) 77.4  (0.7)
Prior to cycle 3 78.8  (0.7) 76.9  (0.7) 80.0  (0.7)
Prior to cycle 5 79.3  (0.7) 77.6  (0.7) 80.8  (0.7)
Prior to cycle 7 80.0  (0.7) 77.5  (0.8) 79.5  (0.8)
Prior to cycle 12 78.3  (0.8) 76.8  (0.8) 79.2  (0.8)
12 months post treatment 78.8  (0.9) 76.0  (0.9) 77.4  (0.9)
5.Secondary Outcome
Title Patient-Reported Peripheral Neuropathy Symptoms
Hide Description Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The Ntx score ranges 0-16 with a large score suggesting less peripheral neuropathy symptoms.
Time Frame 1. Prior to treatment 2. Prior to cycle 3 3. Prior to cycle 5 4. Prior to cycle 7 5. Prior to cycle 12 6. 12 months post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Provided baseline and >= 1 follow-up assessment
Arm/Group Title Arm I (Paclitaxel Poliglumex) Arm II (Paclitaxel) Arm III (Observation)
Hide Arm/Group Description:

Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel Poliglumex: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive no further anticancer treatment until evidence of disease progression.

Clinical Observation: Undergo observation

Laboratory Biomarker Analysis: Correlative studies

Quality-of-Life Assessment: Ancillary studies
Overall Number of Participants Analyzed 374 366 373
Mean (Standard Error)
Unit of Measure: score on a scale
Baseline 11.4  (0.2) 11.7  (0.2) 11.8  (0.2)
Prior to cycle 3 9.6  (0.2) 10.6  (0.2) 11.5  (0.2)
Prior to cycle 5 9.5  (0.2) 11.3  (0.2) 11.9  (0.2)
Prior to cycle 7 9.8  (0.2) 11.3  (0.2) 12.4  (0.2)
Prior to cycle 12 9.4  (0.2) 11.6  (0.2) 12.2  (0.2)
12 months post treatment 10.7  (0.3) 11.7  (0.3) 12.4  (0.2)
Time Frame All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years.
Adverse Event Reporting Description Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
 
Arm/Group Title Arm I (Paclitaxel Poliglumex) Arm II (Paclitaxel) Arm III (Observation)
Hide Arm/Group Description

Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel Poliglumex: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive no further anticancer treatment until evidence of disease progression.

Clinical Observation: Undergo observation

Laboratory Biomarker Analysis: Correlative studies

Quality-of-Life Assessment: Ancillary studies
All-Cause Mortality
Arm I (Paclitaxel Poliglumex) Arm II (Paclitaxel) Arm III (Observation)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   235/387 (60.72%)   242/384 (63.02%)   230/386 (59.59%) 
Hide Serious Adverse Events
Arm I (Paclitaxel Poliglumex) Arm II (Paclitaxel) Arm III (Observation)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   50/379 (13.19%)   39/374 (10.43%)   1/386 (0.26%) 
Blood and lymphatic system disorders       
Neutrophils * 1  2/379 (0.53%)  3/374 (0.80%)  0/386 (0.00%) 
Hemoglobin * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Cardiac disorders       
S/N Arrhythmia: Atrial Fibrillation * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Cardiac General - Other * 1  0/379 (0.00%)  1/374 (0.27%)  0/386 (0.00%) 
Pericardial Effusion * 1  0/379 (0.00%)  1/374 (0.27%)  0/386 (0.00%) 
Pericarditis * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Ear and labyrinth disorders       
Tinnitus * 1  0/379 (0.00%)  1/374 (0.27%)  0/386 (0.00%) 
Eye disorders       
Retinal Detachment * 1  0/379 (0.00%)  1/374 (0.27%)  0/386 (0.00%) 
Dry Eye * 1  0/379 (0.00%)  1/374 (0.27%)  0/386 (0.00%) 
Gastrointestinal disorders       
Obstruction, Gi - Stomach * 1  0/379 (0.00%)  1/374 (0.27%)  0/386 (0.00%) 
Obstruction, Gi - Ileum * 1  0/379 (0.00%)  3/374 (0.80%)  0/386 (0.00%) 
Obstruction, Gi - Colon * 1  0/379 (0.00%)  1/374 (0.27%)  0/386 (0.00%) 
Gastritis * 1  0/379 (0.00%)  1/374 (0.27%)  0/386 (0.00%) 
Ileus * 1  1/379 (0.26%)  2/374 (0.53%)  0/386 (0.00%) 
Obstruction, Gi - Small Bowel Nos * 1  4/379 (1.06%)  6/374 (1.60%)  0/386 (0.00%) 
Colitis * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Vomiting * 1  2/379 (0.53%)  1/374 (0.27%)  0/386 (0.00%) 
Dehydration * 1  2/379 (0.53%)  1/374 (0.27%)  0/386 (0.00%) 
Diarrhea * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
General disorders       
Weight Gain * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Fever * 1  2/379 (0.53%)  0/374 (0.00%)  0/386 (0.00%) 
Insomnia * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Pain - Other * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Pain: Chest Wall * 1  0/379 (0.00%)  0/374 (0.00%)  1/386 (0.26%) 
Pain: Head/Headache * 1  2/379 (0.53%)  0/374 (0.00%)  0/386 (0.00%) 
Pain: Back * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Pain: Bone * 1  0/379 (0.00%)  1/374 (0.27%)  0/386 (0.00%) 
Pain: Stomach * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Pain: Abdominal Pain Nos * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Syndromes - Other * 1  0/379 (0.00%)  1/374 (0.27%)  0/386 (0.00%) 
Hepatobiliary disorders       
Cholecystitis * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Immune system disorders       
Allergic Reaction/Hypersensitivity * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Rhinitis * 1  2/379 (0.53%)  0/374 (0.00%)  0/386 (0.00%) 
Infections and infestations       
Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos * 1  0/379 (0.00%)  1/374 (0.27%)  0/386 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Blood * 1  0/379 (0.00%)  1/374 (0.27%)  0/386 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Wound * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Catheter-Related * 1  0/379 (0.00%)  1/374 (0.27%)  0/386 (0.00%) 
Febrile Neutropenia * 1  0/379 (0.00%)  1/374 (0.27%)  0/386 (0.00%) 
Inf Unknown Anc: Lung (Pneumonia) * 1  0/379 (0.00%)  1/374 (0.27%)  0/386 (0.00%) 
Colitis, Infectious (Eg.C. Difficile) * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Inf Unknown Anc: Pelvis Nos * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Sinus * 1  0/379 (0.00%)  1/374 (0.27%)  0/386 (0.00%) 
Inf Unknown Anc: Bladder (Urinary) * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Inf Unknown Anc: Wound * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Kidney * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Bladder * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Metabolism and nutrition disorders       
Hyponatremia * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Musculoskeletal and connective tissue disorders       
Fracture * 1  1/379 (0.26%)  1/374 (0.27%)  0/386 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
2nd Mal: Poss. Related To Cancer Rx * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Nervous system disorders       
Syncope * 1  0/379 (0.00%)  1/374 (0.27%)  0/386 (0.00%) 
Encephalopathy * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Mood Alteration - Depression * 1  1/379 (0.26%)  1/374 (0.27%)  0/386 (0.00%) 
Mood Alteration - Anxiety * 1  1/379 (0.26%)  1/374 (0.27%)  0/386 (0.00%) 
Cns Ischemia * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Dizziness * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Neuropathy-Sensory * 1  0/379 (0.00%)  1/374 (0.27%)  0/386 (0.00%) 
Neuropathy-Motor * 1  1/379 (0.26%)  2/374 (0.53%)  0/386 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Pulmonary: Other * 1  0/379 (0.00%)  1/374 (0.27%)  0/386 (0.00%) 
Dyspnea * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Skin and subcutaneous tissue disorders       
Nail Changes * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Wound Complication, Non-Infectious * 1  2/379 (0.53%)  1/374 (0.27%)  0/386 (0.00%) 
Vascular disorders       
Thrombosis/Thrombus/Embolism * 1  4/379 (1.06%)  2/374 (0.53%)  0/386 (0.00%) 
1
Term from vocabulary, CTCAE (3.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (Paclitaxel Poliglumex) Arm II (Paclitaxel) Arm III (Observation)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   378/379 (99.74%)   372/374 (99.47%)   312/386 (80.83%) 
Blood and lymphatic system disorders       
Neutrophils * 1  190/379 (50.13%)  213/374 (56.95%)  28/386 (7.25%) 
Platelets * 1  115/379 (30.34%)  65/374 (17.38%)  14/386 (3.63%) 
Blood/Bone Marrow - Other * 1  5/379 (1.32%)  3/374 (0.80%)  2/386 (0.52%) 
Bone Marrow Cellularity * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Leukocytes * 1  229/379 (60.42%)  231/374 (61.76%)  44/386 (11.40%) 
Lymphopenia * 1  5/379 (1.32%)  10/374 (2.67%)  2/386 (0.52%) 
Hemoglobin * 1  270/379 (71.24%)  283/374 (75.67%)  83/386 (21.50%) 
Lymphatics - Other * 1  3/379 (0.79%)  2/374 (0.53%)  0/386 (0.00%) 
Lymphocele * 1  0/379 (0.00%)  0/374 (0.00%)  1/386 (0.26%) 
Edema: Viscera * 1  0/379 (0.00%)  1/374 (0.27%)  0/386 (0.00%) 
Edema: Trunk/Genital * 1  2/379 (0.53%)  5/374 (1.34%)  2/386 (0.52%) 
Edema: Limb * 1  72/379 (19.00%)  70/374 (18.72%)  31/386 (8.03%) 
Edema: Head And Neck * 1  5/379 (1.32%)  7/374 (1.87%)  5/386 (1.30%) 
Dermal Change * 1  0/379 (0.00%)  0/374 (0.00%)  1/386 (0.26%) 
Cardiac disorders       
S/N Arrhythmia: Atrial Fibrillation * 1  1/379 (0.26%)  0/374 (0.00%)  1/386 (0.26%) 
Palpitations * 1  8/379 (2.11%)  10/374 (2.67%)  4/386 (1.04%) 
Cardiac Arrhythmia - Other * 1  0/379 (0.00%)  0/374 (0.00%)  2/386 (0.52%) 
Ventricular Arrhythmia - Tachycardia * 1  1/379 (0.26%)  3/374 (0.80%)  0/386 (0.00%) 
S/N Arrhythmia: Sinus Tachycardia * 1  2/379 (0.53%)  2/374 (0.53%)  1/386 (0.26%) 
Vasovagal Episode * 1  0/379 (0.00%)  0/374 (0.00%)  1/386 (0.26%) 
S/N Arrhythmia: Sinus Bradycardia * 1  0/379 (0.00%)  1/374 (0.27%)  0/386 (0.00%) 
Hypertension * 1  28/379 (7.39%)  28/374 (7.49%)  23/386 (5.96%) 
Valvular Heart Disease * 1  0/379 (0.00%)  0/374 (0.00%)  1/386 (0.26%) 
Left Venticular Diastolic Dysfunction * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Lt Ventricular Systolic Dysfunction * 1  0/379 (0.00%)  0/374 (0.00%)  1/386 (0.26%) 
Cardiac General - Other * 1  5/379 (1.32%)  2/374 (0.53%)  1/386 (0.26%) 
Hypotension * 1  4/379 (1.06%)  4/374 (1.07%)  1/386 (0.26%) 
Ear and labyrinth disorders       
Otitis Middle Ear * 1  1/379 (0.26%)  2/374 (0.53%)  0/386 (0.00%) 
Auditory/Ear - Other * 1  1/379 (0.26%)  3/374 (0.80%)  2/386 (0.52%) 
Otitis External Ear * 1  1/379 (0.26%)  0/374 (0.00%)  1/386 (0.26%) 
Hearing (Without Monitoring Program) * 1  5/379 (1.32%)  4/374 (1.07%)  5/386 (1.30%) 
Tinnitus * 1  23/379 (6.07%)  29/374 (7.75%)  14/386 (3.63%) 
Hearing (Monitoring Program) * 1  0/379 (0.00%)  2/374 (0.53%)  0/386 (0.00%) 
Endocrine disorders       
Hot Flashes * 1  53/379 (13.98%)  52/374 (13.90%)  43/386 (11.14%) 
Diabetes * 1  3/379 (0.79%)  1/374 (0.27%)  3/386 (0.78%) 
Adh Secrection Abnormality * 1  0/379 (0.00%)  0/374 (0.00%)  1/386 (0.26%) 
Hypoparathyroidism * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Hyperthyroidism * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Endocrine - Other * 1  2/379 (0.53%)  2/374 (0.53%)  1/386 (0.26%) 
Hypothyroidism * 1  3/379 (0.79%)  1/374 (0.27%)  3/386 (0.78%) 
Eye disorders       
Ocular/Visual - Other * 1  4/379 (1.06%)  9/374 (2.41%)  1/386 (0.26%) 
Nystagmus * 1  0/379 (0.00%)  0/374 (0.00%)  1/386 (0.26%) 
Watery Eye * 1  0/379 (0.00%)  5/374 (1.34%)  0/386 (0.00%) 
Glaucoma * 1  1/379 (0.26%)  1/374 (0.27%)  0/386 (0.00%) 
Dry Eye * 1  2/379 (0.53%)  5/374 (1.34%)  2/386 (0.52%) 
Ocular Surface Disease * 1  0/379 (0.00%)  1/374 (0.27%)  0/386 (0.00%) 
Cataract * 1  2/379 (0.53%)  2/374 (0.53%)  1/386 (0.26%) 
Photophobia * 1  1/379 (0.26%)  1/374 (0.27%)  2/386 (0.52%) 
Flashing Lights/Floaters * 1  3/379 (0.79%)  5/374 (1.34%)  3/386 (0.78%) 
Diplopia * 1  0/379 (0.00%)  1/374 (0.27%)  0/386 (0.00%) 
Blurred Vision * 1  19/379 (5.01%)  30/374 (8.02%)  12/386 (3.11%) 
Eyelid Dysfunction * 1  0/379 (0.00%)  1/374 (0.27%)  1/386 (0.26%) 
Gastrointestinal disorders       
Proctitis * 1  0/379 (0.00%)  1/374 (0.27%)  0/386 (0.00%) 
Flatulence * 1  7/379 (1.85%)  11/374 (2.94%)  13/386 (3.37%) 
Ulcer,gi - Esophagus * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Dental: Periodontal * 1  2/379 (0.53%)  1/374 (0.27%)  0/386 (0.00%) 
Obstruction, Gi - Colon * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Gastritis * 1  1/379 (0.26%)  5/374 (1.34%)  3/386 (0.78%) 
Esophagitis * 1  0/379 (0.00%)  1/374 (0.27%)  1/386 (0.26%) 
Hemorrhoids * 1  5/379 (1.32%)  4/374 (1.07%)  3/386 (0.78%) 
Heartburn * 1  35/379 (9.23%)  32/374 (8.56%)  19/386 (4.92%) 
Dental: Teeth * 1  2/379 (0.53%)  7/374 (1.87%)  0/386 (0.00%) 
Mucositis (Functional/Sympt) - Pharynx * 1  1/379 (0.26%)  1/374 (0.27%)  0/386 (0.00%) 
Ascites * 1  1/379 (0.26%)  0/374 (0.00%)  2/386 (0.52%) 
Ileus * 1  0/379 (0.00%)  2/374 (0.53%)  0/386 (0.00%) 
Dental: Teeth Development * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Dysphagia * 1  5/379 (1.32%)  4/374 (1.07%)  1/386 (0.26%) 
Distention * 1  25/379 (6.60%)  23/374 (6.15%)  34/386 (8.81%) 
Taste Alteration * 1  11/379 (2.90%)  19/374 (5.08%)  2/386 (0.52%) 
Incontinence, Anal * 1  2/379 (0.53%)  5/374 (1.34%)  2/386 (0.52%) 
Dry Mouth * 1  3/379 (0.79%)  7/374 (1.87%)  1/386 (0.26%) 
Mucositis (Functional/Sympt) - Oral Cavity * 1  6/379 (1.58%)  15/374 (4.01%)  2/386 (0.52%) 
Obstruction, Gi - Small Bowel Nos * 1  3/379 (0.79%)  1/374 (0.27%)  11/386 (2.85%) 
Obstruction, Gi - Jejunum * 1  0/379 (0.00%)  1/374 (0.27%)  0/386 (0.00%) 
Mucositis (Clinical Exam) - Oral Cavity * 1  15/379 (3.96%)  21/374 (5.61%)  1/386 (0.26%) 
Vomiting * 1  53/379 (13.98%)  41/374 (10.96%)  36/386 (9.33%) 
Anorexia * 1  41/379 (10.82%)  46/374 (12.30%)  21/386 (5.44%) 
Dehydration * 1  5/379 (1.32%)  3/374 (0.80%)  3/386 (0.78%) 
Constipation * 1  156/379 (41.16%)  158/374 (42.25%)  88/386 (22.80%) 
Nausea * 1  145/379 (38.26%)  137/374 (36.63%)  63/386 (16.32%) 
Gastrointestinal - Other * 1  9/379 (2.37%)  10/374 (2.67%)  9/386 (2.33%) 
Diarrhea * 1  88/379 (23.22%)  97/374 (25.94%)  56/386 (14.51%) 
Prolapse Of Stoma, Gi * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
General disorders       
Constitutional Symptoms - Other * 1  3/379 (0.79%)  6/374 (1.60%)  6/386 (1.55%) 
Sweating * 1  5/379 (1.32%)  14/374 (3.74%)  7/386 (1.81%) 
Weight Gain * 1  45/379 (11.87%)  46/374 (12.30%)  27/386 (6.99%) 
Fever * 1  27/379 (7.12%)  25/374 (6.68%)  8/386 (2.07%) 
Weight Loss * 1  6/379 (1.58%)  7/374 (1.87%)  10/386 (2.59%) 
Hypothermia * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Rigors/Chills * 1  9/379 (2.37%)  12/374 (3.21%)  1/386 (0.26%) 
Fatigue * 1  254/379 (67.02%)  277/374 (74.06%)  143/386 (37.05%) 
Insomnia * 1  69/379 (18.21%)  81/374 (21.66%)  50/386 (12.95%) 
Pain - Other * 1  19/379 (5.01%)  24/374 (6.42%)  22/386 (5.70%) 
Pain: Urethra * 1  9/379 (2.37%)  2/374 (0.53%)  2/386 (0.52%) 
Pain: Perineum * 1  0/379 (0.00%)  2/374 (0.53%)  0/386 (0.00%) 
Pain: Pelvis * 1  20/379 (5.28%)  14/374 (3.74%)  18/386 (4.66%) 
Pain: Breast * 1  7/379 (1.85%)  2/374 (0.53%)  3/386 (0.78%) 
Pain: Vagina * 1  3/379 (0.79%)  7/374 (1.87%)  7/386 (1.81%) 
Pain: Chest /Thorax Nos * 1  21/379 (5.54%)  18/374 (4.81%)  7/386 (1.81%) 
Pain: Chest Wall * 1  12/379 (3.17%)  4/374 (1.07%)  3/386 (0.78%) 
Pain: Throat/Pharynx/Larynx * 1  6/379 (1.58%)  18/374 (4.81%)  0/386 (0.00%) 
Pain: Pleura * 1  3/379 (0.79%)  0/374 (0.00%)  1/386 (0.26%) 
Pain: Eye * 1  1/379 (0.26%)  3/374 (0.80%)  0/386 (0.00%) 
Pain: Head/Headache * 1  62/379 (16.36%)  52/374 (13.90%)  22/386 (5.70%) 
Pain: Neck * 1  6/379 (1.58%)  7/374 (1.87%)  7/386 (1.81%) 
Pain: Intestine * 1  2/379 (0.53%)  1/374 (0.27%)  0/386 (0.00%) 
Pain: Extremity-Limb * 1  61/379 (16.09%)  76/374 (20.32%)  30/386 (7.77%) 
Pain: Buttock * 1  1/379 (0.26%)  2/374 (0.53%)  0/386 (0.00%) 
Pain: Back * 1  52/379 (13.72%)  52/374 (13.90%)  48/386 (12.44%) 
Pain: Joint * 1  106/379 (27.97%)  133/374 (35.56%)  81/386 (20.98%) 
Pain: Bone * 1  21/379 (5.54%)  25/374 (6.68%)  9/386 (2.33%) 
Pain: Gallbladder * 1  1/379 (0.26%)  0/374 (0.00%)  1/386 (0.26%) 
Pain: Kidney * 1  0/379 (0.00%)  2/374 (0.53%)  0/386 (0.00%) 
Pain: Bladder * 1  1/379 (0.26%)  6/374 (1.60%)  2/386 (0.52%) 
Pain: Pain Nos * 1  5/379 (1.32%)  7/374 (1.87%)  2/386 (0.52%) 
Pain: Stomach * 1  6/379 (1.58%)  5/374 (1.34%)  1/386 (0.26%) 
Pain: Rectum * 1  0/379 (0.00%)  1/374 (0.27%)  2/386 (0.52%) 
Pain: Oral Cavity * 1  1/379 (0.26%)  1/374 (0.27%)  1/386 (0.26%) 
Pain: Dental/Teeth/Peridontal * 1  4/379 (1.06%)  6/374 (1.60%)  2/386 (0.52%) 
Pain: Abdominal Pain Nos * 1  111/379 (29.29%)  102/374 (27.27%)  120/386 (31.09%) 
Pain: Scalp * 1  0/379 (0.00%)  1/374 (0.27%)  0/386 (0.00%) 
Pain: Oral - Gums * 1  0/379 (0.00%)  2/374 (0.53%)  0/386 (0.00%) 
Pain: Skin * 1  0/379 (0.00%)  1/374 (0.27%)  0/386 (0.00%) 
Pain: Lip * 1  1/379 (0.26%)  1/374 (0.27%)  0/386 (0.00%) 
Pain: Middle Ear * 1  2/379 (0.53%)  3/374 (0.80%)  3/386 (0.78%) 
Pain: External Ear * 1  1/379 (0.26%)  3/374 (0.80%)  0/386 (0.00%) 
Pain: Cardiac/ Heart * 1  2/379 (0.53%)  0/374 (0.00%)  1/386 (0.26%) 
Pain: Face * 1  1/379 (0.26%)  2/374 (0.53%)  0/386 (0.00%) 
Pain: Liver * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Pain: Muscle * 1  77/379 (20.32%)  102/374 (27.27%)  44/386 (11.40%) 
Pain: Anus * 1  1/379 (0.26%)  0/374 (0.00%)  1/386 (0.26%) 
Pain: Neuralgia * 1  7/379 (1.85%)  9/374 (2.41%)  1/386 (0.26%) 
Pain: Sinus * 1  1/379 (0.26%)  3/374 (0.80%)  0/386 (0.00%) 
Flu-Like Syndrome * 1  6/379 (1.58%)  6/374 (1.60%)  3/386 (0.78%) 
Hepatobiliary disorders       
Hepatobiliary/Pancreas - Other * 1  1/379 (0.26%)  1/374 (0.27%)  0/386 (0.00%) 
Cholecystitis * 1  0/379 (0.00%)  0/374 (0.00%)  1/386 (0.26%) 
Liver Dysfunction * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Immune system disorders       
Allergy/Immunology - Other * 1  1/379 (0.26%)  1/374 (0.27%)  2/386 (0.52%) 
Allergic Reaction/Hypersensitivity * 1  26/379 (6.86%)  12/374 (3.21%)  4/386 (1.04%) 
Rhinitis * 1  19/379 (5.01%)  31/374 (8.29%)  19/386 (4.92%) 
Autoimmune Reaction * 1  0/379 (0.00%)  0/374 (0.00%)  1/386 (0.26%) 
Infections and infestations       
Inf W/Gr 3 Or 4 Anc: Skin (Cellulitis) * 1  0/379 (0.00%)  1/374 (0.27%)  0/386 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Vulva * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos * 1  13/379 (3.43%)  12/374 (3.21%)  3/386 (0.78%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Nose * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Lip/Perioral * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia) * 1  3/379 (0.79%)  1/374 (0.27%)  0/386 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Eye Nos * 1  0/379 (0.00%)  2/374 (0.53%)  0/386 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Soft Tissue Nos * 1  3/379 (0.79%)  0/374 (0.00%)  0/386 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Peristomal * 1  1/379 (0.26%)  1/374 (0.27%)  0/386 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Blood * 1  0/379 (0.00%)  1/374 (0.27%)  0/386 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Wound * 1  2/379 (0.53%)  1/374 (0.27%)  3/386 (0.78%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Oral Cavity-Gums * 1  2/379 (0.53%)  0/374 (0.00%)  0/386 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Otitis Media Nos * 1  2/379 (0.53%)  5/374 (1.34%)  2/386 (0.52%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis) * 1  3/379 (0.79%)  5/374 (1.34%)  1/386 (0.26%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Lip/Perioral * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Inf Unknown Anc: Nerve-Peripheral * 1  0/379 (0.00%)  0/374 (0.00%)  1/386 (0.26%) 
Inf Unknown Anc: Lung (Pneumonia) * 1  0/379 (0.00%)  3/374 (0.80%)  1/386 (0.26%) 
Inf Unknown Anc: Sinus * 1  4/379 (1.06%)  6/374 (1.60%)  6/386 (1.55%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Dental-Tooth * 1  2/379 (0.53%)  1/374 (0.27%)  1/386 (0.26%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Colon * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos * 1  13/379 (3.43%)  16/374 (4.28%)  3/386 (0.78%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Abdomen Nos * 1  3/379 (0.79%)  0/374 (0.00%)  0/386 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Ungual (Nails) * 1  1/379 (0.26%)  0/374 (0.00%)  1/386 (0.26%) 
Inf Unknown Anc: Stomach * 1  0/379 (0.00%)  1/374 (0.27%)  0/386 (0.00%) 
Infection - Other * 1  9/379 (2.37%)  16/374 (4.28%)  4/386 (1.04%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Nerve-Peripheral * 1  0/379 (0.00%)  1/374 (0.27%)  0/386 (0.00%) 
Inf Unknown Anc: Vulva * 1  0/379 (0.00%)  0/374 (0.00%)  1/386 (0.26%) 
Inf Unknown Anc: Vagina * 1  1/379 (0.26%)  2/374 (0.53%)  1/386 (0.26%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Bronchus * 1  5/379 (1.32%)  1/374 (0.27%)  1/386 (0.26%) 
Inf Unknown Anc: Upper Airway Nos * 1  2/379 (0.53%)  1/374 (0.27%)  3/386 (0.78%) 
Inf Unknown Anc: Upper Aerodigestive * 1  0/379 (0.00%)  1/374 (0.27%)  1/386 (0.26%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Pharynx * 1  0/379 (0.00%)  1/374 (0.27%)  2/386 (0.52%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Vagina * 1  3/379 (0.79%)  4/374 (1.07%)  1/386 (0.26%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Sinus * 1  6/379 (1.58%)  5/374 (1.34%)  5/386 (1.30%) 
Inf Unknown Anc: Pharynx * 1  0/379 (0.00%)  0/374 (0.00%)  1/386 (0.26%) 
Inf Unknown Anc: Bronchus * 1  1/379 (0.26%)  0/374 (0.00%)  1/386 (0.26%) 
Inf Unknown Anc: Eye Nos * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Inf Unknown Anc: Joint * 1  0/379 (0.00%)  0/374 (0.00%)  1/386 (0.26%) 
Inf Unknown Anc: Lymphatic * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Inf Unknown Anc: Urinary Tract Nos * 1  7/379 (1.85%)  8/374 (2.14%)  3/386 (0.78%) 
Inf Unknown Anc: Bladder (Urinary) * 1  4/379 (1.06%)  4/374 (1.07%)  3/386 (0.78%) 
Inf Unknown Anc: Wound * 1  0/379 (0.00%)  0/374 (0.00%)  2/386 (0.52%) 
Inf Unknown Anc: Oral Cavity-Gums * 1  0/379 (0.00%)  0/374 (0.00%)  1/386 (0.26%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Foreign Body * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Inf Unknown Anc: Dental-Tooth * 1  0/379 (0.00%)  0/374 (0.00%)  1/386 (0.26%) 
Inf Unknown Anc: Appendix * 1  0/379 (0.00%)  0/374 (0.00%)  1/386 (0.26%) 
Inf Unknown Anc: Anal/Perianal * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Inf Unknown Anc: Abdomen Nos * 1  1/379 (0.26%)  1/374 (0.27%)  0/386 (0.00%) 
Inf Unknown Anc: Skin (Cellulitis) * 1  1/379 (0.26%)  1/374 (0.27%)  4/386 (1.04%) 
Inf Unknown Anc: Peristomal * 1  0/379 (0.00%)  0/374 (0.00%)  1/386 (0.26%) 
Inf Unknown Anc: Middle Ear * 1  0/379 (0.00%)  1/374 (0.27%)  1/386 (0.26%) 
Inf Unknown Anc: External Ear * 1  1/379 (0.26%)  2/374 (0.53%)  1/386 (0.26%) 
Inf W/Gr 3 Or 4 Anc: Pelvis Nos * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Upper Airway Nos * 1  0/379 (0.00%)  1/374 (0.27%)  0/386 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Sinus * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Kidney * 1  0/379 (0.00%)  1/374 (0.27%)  0/386 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Bladder * 1  3/379 (0.79%)  6/374 (1.60%)  3/386 (0.78%) 
Inf W/Gr 3 Or 4 Anc: Urinary Tract Nos * 1  1/379 (0.26%)  1/374 (0.27%)  0/386 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Catheter-Related * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Metabolism and nutrition disorders       
Ast * 1  69/379 (18.21%)  24/374 (6.42%)  12/386 (3.11%) 
Gfr * 1  2/379 (0.53%)  4/374 (1.07%)  3/386 (0.78%) 
Metabolic/Laboratory - Other * 1  12/379 (3.17%)  13/374 (3.48%)  4/386 (1.04%) 
Alkalosis * 1  0/379 (0.00%)  1/374 (0.27%)  0/386 (0.00%) 
Cholesterol,serum High * 1  6/379 (1.58%)  6/374 (1.60%)  4/386 (1.04%) 
Proteinuria * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Hemoglobinuria * 1  0/379 (0.00%)  0/374 (0.00%)  1/386 (0.26%) 
Creatinine * 1  14/379 (3.69%)  21/374 (5.61%)  11/386 (2.85%) 
Hypoalbuminemia * 1  11/379 (2.90%)  12/374 (3.21%)  6/386 (1.55%) 
Alt * 1  36/379 (9.50%)  27/374 (7.22%)  8/386 (2.07%) 
Alkaline Phosphatase * 1  38/379 (10.03%)  32/374 (8.56%)  16/386 (4.15%) 
Bilirubin * 1  6/379 (1.58%)  2/374 (0.53%)  4/386 (1.04%) 
Hypermagnesemia * 1  3/379 (0.79%)  4/374 (1.07%)  1/386 (0.26%) 
Hypophosphatemia * 1  2/379 (0.53%)  1/374 (0.27%)  0/386 (0.00%) 
Hyponatremia * 1  22/379 (5.80%)  15/374 (4.01%)  8/386 (2.07%) 
Hyperuricemia * 1  1/379 (0.26%)  3/374 (0.80%)  0/386 (0.00%) 
Hypertriglyceridemia * 1  1/379 (0.26%)  4/374 (1.07%)  1/386 (0.26%) 
Bicarbonate, Serum-Low * 1  0/379 (0.00%)  1/374 (0.27%)  1/386 (0.26%) 
Amylase * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Hypernatremia * 1  5/379 (1.32%)  9/374 (2.41%)  4/386 (1.04%) 
Hypocalcemia * 1  15/379 (3.96%)  10/374 (2.67%)  5/386 (1.30%) 
Hyperkalemia * 1  4/379 (1.06%)  6/374 (1.60%)  1/386 (0.26%) 
Hyperglycemia * 1  79/379 (20.84%)  67/374 (17.91%)  27/386 (6.99%) 
Hypokalemia * 1  33/379 (8.71%)  28/374 (7.49%)  13/386 (3.37%) 
Hypoglycemia * 1  10/379 (2.64%)  14/374 (3.74%)  9/386 (2.33%) 
Hypercalcemia * 1  13/379 (3.43%)  11/374 (2.94%)  9/386 (2.33%) 
Hypomagnesemia * 1  37/379 (9.76%)  29/374 (7.75%)  10/386 (2.59%) 
Musculoskeletal and connective tissue disorders       
Trismus * 1  0/379 (0.00%)  0/374 (0.00%)  1/386 (0.26%) 
Musculoskeletal/St: Other * 1  10/379 (2.64%)  12/374 (3.21%)  1/386 (0.26%) 
Osteoporosis * 1  3/379 (0.79%)  2/374 (0.53%)  3/386 (0.78%) 
Joint-Function * 1  2/379 (0.53%)  2/374 (0.53%)  5/386 (1.30%) 
Joint Effusion * 1  1/379 (0.26%)  1/374 (0.27%)  1/386 (0.26%) 
Fracture * 1  4/379 (1.06%)  3/374 (0.80%)  7/386 (1.81%) 
Gait/Walking * 1  6/379 (1.58%)  1/374 (0.27%)  1/386 (0.26%) 
Arthritis * 1  15/379 (3.96%)  13/374 (3.48%)  14/386 (3.63%) 
Muscle Weakness - Whole Body/Generalized * 1  10/379 (2.64%)  16/374 (4.28%)  11/386 (2.85%) 
Muscle Weakness - Trunk * 1  0/379 (0.00%)  1/374 (0.27%)  1/386 (0.26%) 
Muscle Weakness - Left-Sided * 1  1/379 (0.26%)  1/374 (0.27%)  0/386 (0.00%) 
Muscle Weakness - Facial * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Muscle Weakness - Extremity-Upper * 1  1/379 (0.26%)  2/374 (0.53%)  3/386 (0.78%) 
Muscle Weakness - Extremity-Lower * 1  6/379 (1.58%)  10/374 (2.67%)  9/386 (2.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
2nd Mal: Poss. Related To Cancer Rx * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Nervous system disorders       
Syncope * 1  2/379 (0.53%)  1/374 (0.27%)  1/386 (0.26%) 
Involuntary Movement * 1  1/379 (0.26%)  4/374 (1.07%)  1/386 (0.26%) 
Psychosis * 1  0/379 (0.00%)  1/374 (0.27%)  0/386 (0.00%) 
Neurology - Other * 1  1/379 (0.26%)  8/374 (2.14%)  5/386 (1.30%) 
Mental Status * 1  1/379 (0.26%)  0/374 (0.00%)  1/386 (0.26%) 
Mood Alteration - Depression * 1  44/379 (11.61%)  62/374 (16.58%)  47/386 (12.18%) 
Mood Alteration - Anxiety * 1  43/379 (11.35%)  53/374 (14.17%)  43/386 (11.14%) 
Mood Alteration - Agitation * 1  6/379 (1.58%)  10/374 (2.67%)  1/386 (0.26%) 
Tremor * 1  3/379 (0.79%)  2/374 (0.53%)  2/386 (0.52%) 
Speech Impairment * 1  1/379 (0.26%)  0/374 (0.00%)  1/386 (0.26%) 
Seizure * 1  1/379 (0.26%)  0/374 (0.00%)  1/386 (0.26%) 
Personality * 1  2/379 (0.53%)  0/374 (0.00%)  0/386 (0.00%) 
Irritability * 1  0/379 (0.00%)  3/374 (0.80%)  1/386 (0.26%) 
Somnolence * 1  0/379 (0.00%)  1/374 (0.27%)  1/386 (0.26%) 
Cognitive Disturbance * 1  7/379 (1.85%)  5/374 (1.34%)  1/386 (0.26%) 
Ataxia * 1  4/379 (1.06%)  5/374 (1.34%)  1/386 (0.26%) 
Confusion * 1  2/379 (0.53%)  3/374 (0.80%)  0/386 (0.00%) 
Memory Impairment * 1  17/379 (4.49%)  37/374 (9.89%)  14/386 (3.63%) 
Dizziness * 1  38/379 (10.03%)  42/374 (11.23%)  17/386 (4.40%) 
Neuropathy,cranial - Cn Viii Hearing/Balance * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Neuropathy,cranial - Cn V Motor-Jaw Muscles * 1  0/379 (0.00%)  1/374 (0.27%)  1/386 (0.26%) 
Neuropathy-Sensory * 1  318/379 (83.91%)  294/374 (78.61%)  175/386 (45.34%) 
Neuropathy-Motor * 1  33/379 (8.71%)  31/374 (8.29%)  15/386 (3.89%) 
Renal and urinary disorders       
Renal/Genitourinary - Other * 1  7/379 (1.85%)  4/374 (1.07%)  3/386 (0.78%) 
Leak, Gu - Bladder * 1  3/379 (0.79%)  0/374 (0.00%)  0/386 (0.00%) 
Cystitis * 1  3/379 (0.79%)  2/374 (0.53%)  4/386 (1.04%) 
Urinary Color Change * 1  0/379 (0.00%)  3/374 (0.80%)  1/386 (0.26%) 
Urinary Retention * 1  1/379 (0.26%)  2/374 (0.53%)  3/386 (0.78%) 
Obstruction, Gu - Ureter * 1  1/379 (0.26%)  0/374 (0.00%)  1/386 (0.26%) 
Incontinence, Urinary * 1  16/379 (4.22%)  19/374 (5.08%)  13/386 (3.37%) 
Bladder Spasm * 1  1/379 (0.26%)  4/374 (1.07%)  3/386 (0.78%) 
Urinary Frequency * 1  15/379 (3.96%)  30/374 (8.02%)  24/386 (6.22%) 
Reproductive system and breast disorders       
Libido * 1  5/379 (1.32%)  2/374 (0.53%)  6/386 (1.55%) 
Vaginal Dryness * 1  11/379 (2.90%)  9/374 (2.41%)  8/386 (2.07%) 
Sexual/Reproductive Function: Other * 1  2/379 (0.53%)  1/374 (0.27%)  3/386 (0.78%) 
Vaginitis * 1  3/379 (0.79%)  6/374 (1.60%)  5/386 (1.30%) 
Vaginal Stenosis * 1  0/379 (0.00%)  0/374 (0.00%)  1/386 (0.26%) 
Vaginal Discharge * 1  4/379 (1.06%)  9/374 (2.41%)  4/386 (1.04%) 
Respiratory, thoracic and mediastinal disorders       
Pulmonary: Other * 1  3/379 (0.79%)  6/374 (1.60%)  2/386 (0.52%) 
Airway Obstruction - Bronchus * 1  0/379 (0.00%)  0/374 (0.00%)  1/386 (0.26%) 
Nasal/Paranasal Reactions * 1  11/379 (2.90%)  13/374 (3.48%)  6/386 (1.55%) 
Bronchospasm * 1  2/379 (0.53%)  2/374 (0.53%)  1/386 (0.26%) 
Voice Changes * 1  6/379 (1.58%)  3/374 (0.80%)  0/386 (0.00%) 
Pneumothorax * 1  0/379 (0.00%)  1/374 (0.27%)  0/386 (0.00%) 
Hypoxia * 1  0/379 (0.00%)  1/374 (0.27%)  0/386 (0.00%) 
Hiccoughs * 1  0/379 (0.00%)  1/374 (0.27%)  0/386 (0.00%) 
Cough * 1  52/379 (13.72%)  75/374 (20.05%)  31/386 (8.03%) 
Pleural Effusion * 1  0/379 (0.00%)  2/374 (0.53%)  2/386 (0.52%) 
Dyspnea * 1  66/379 (17.41%)  72/374 (19.25%)  41/386 (10.62%) 
Skin and subcutaneous tissue disorders       
Nail Changes * 1  12/379 (3.17%)  19/374 (5.08%)  3/386 (0.78%) 
Photosensitivity * 1  1/379 (0.26%)  3/374 (0.80%)  0/386 (0.00%) 
Injection Site Reaction * 1  0/379 (0.00%)  3/374 (0.80%)  0/386 (0.00%) 
Hair Loss/Alopecia (Scalp Or Body) * 1  135/379 (35.62%)  239/374 (63.90%)  76/386 (19.69%) 
Induration * 1  0/379 (0.00%)  0/374 (0.00%)  2/386 (0.52%) 
Wound Complication, Non-Infectious * 1  4/379 (1.06%)  6/374 (1.60%)  6/386 (1.55%) 
Bruising * 1  13/379 (3.43%)  13/374 (3.48%)  10/386 (2.59%) 
Acne * 1  3/379 (0.79%)  2/374 (0.53%)  0/386 (0.00%) 
Rash * 1  50/379 (13.19%)  46/374 (12.30%)  20/386 (5.18%) 
Striae * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Dry Skin * 1  9/379 (2.37%)  11/374 (2.94%)  6/386 (1.55%) 
Pruritus * 1  18/379 (4.75%)  21/374 (5.61%)  12/386 (3.11%) 
Burn * 1  2/379 (0.53%)  1/374 (0.27%)  0/386 (0.00%) 
Urticaria * 1  4/379 (1.06%)  2/374 (0.53%)  2/386 (0.52%) 
Flushing * 1  22/379 (5.80%)  20/374 (5.35%)  2/386 (0.52%) 
Dermatology/Skin - Other * 1  9/379 (2.37%)  12/374 (3.21%)  7/386 (1.81%) 
Hyperpigmentation * 1  2/379 (0.53%)  1/374 (0.27%)  0/386 (0.00%) 
Ulceration * 1  0/379 (0.00%)  1/374 (0.27%)  3/386 (0.78%) 
Surgical and medical procedures       
Intra-Op Injury: Abdomen Nos * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Vascular disorders       
Inr * 1  6/379 (1.58%)  4/374 (1.07%)  2/386 (0.52%) 
Coagulopathy - Other * 1  1/379 (0.26%)  0/374 (0.00%)  2/386 (0.52%) 
Ptt * 1  7/379 (1.85%)  5/374 (1.34%)  4/386 (1.04%) 
Hemorrhage, Gu - Stoma * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Hemorrhage, Gu - Vagina * 1  9/379 (2.37%)  6/374 (1.60%)  1/386 (0.26%) 
Hemorrhage, Gu - Urethra * 1  0/379 (0.00%)  1/374 (0.27%)  0/386 (0.00%) 
Hemorrhage, Gi - Rectum * 1  6/379 (1.58%)  5/374 (1.34%)  5/386 (1.30%) 
Hemorrhage, Gi - Upper Gi Nos * 1  0/379 (0.00%)  1/374 (0.27%)  0/386 (0.00%) 
Hemorrhage/Pulmonary - Nose * 1  19/379 (5.01%)  8/374 (2.14%)  1/386 (0.26%) 
Hematoma * 1  3/379 (0.79%)  1/374 (0.27%)  0/386 (0.00%) 
Hemorrhage, Gi - Anus * 1  1/379 (0.26%)  1/374 (0.27%)  0/386 (0.00%) 
Hemorrhage, Gi - Esophagus * 1  0/379 (0.00%)  0/374 (0.00%)  1/386 (0.26%) 
Hemorrhage, Gi - Lower Gi Nos * 1  0/379 (0.00%)  1/374 (0.27%)  0/386 (0.00%) 
Hemorrhage, Gi - Oral Cavity * 1  3/379 (0.79%)  1/374 (0.27%)  0/386 (0.00%) 
Hemorrhage, Gu - Bladder * 1  0/379 (0.00%)  3/374 (0.80%)  2/386 (0.52%) 
Petechiae * 1  1/379 (0.26%)  0/374 (0.00%)  0/386 (0.00%) 
Hemorrhage/Bleeding - Other * 1  3/379 (0.79%)  1/374 (0.27%)  1/386 (0.26%) 
Vascular - Other * 1  1/379 (0.26%)  2/374 (0.53%)  1/386 (0.26%) 
Vein Injury - Extremity-Lower * 1  0/379 (0.00%)  1/374 (0.27%)  0/386 (0.00%) 
Thrombosis/Embolism (Vascular Access-Related) * 1  0/379 (0.00%)  2/374 (0.53%)  0/386 (0.00%) 
Thrombosis/Thrombus/Embolism * 1  2/379 (0.53%)  3/374 (0.80%)  2/386 (0.52%) 
Phlebitis * 1  0/379 (0.00%)  0/374 (0.00%)  1/386 (0.26%) 
1
Term from vocabulary, CTCAE (3.0)
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Christopher Purdy on behalf of Austin Miller PhD
Organization: NRG Oncology
Phone: (716) 845-1300 ext 2296
EMail: purdyc@nrgoncology.org
Layout table for additonal information
Responsible Party: GOG Foundation
ClinicalTrials.gov Identifier: NCT00108745    
Other Study ID Numbers: GOG-0212
NCI-2009-00586 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
07-117
CDR0000422427
GOG-0212
GOG-0212 ( Other Identifier: NRG Oncology )
GOG-0212 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: April 18, 2005
First Posted: April 19, 2005
Results First Submitted: February 22, 2021
Results First Posted: April 1, 2021
Last Update Posted: September 30, 2021