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Doxorubicin Hydrochloride, Cisplatin, and Paclitaxel or Carboplatin and Paclitaxel in Treating Patients With Stage III-IV or Recurrent Endometrial 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: NCT00063999
Recruitment Status : Active, not recruiting
First Posted : July 9, 2003
Results First Posted : April 23, 2018
Last Update Posted : May 28, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Recurrent Uterine Corpus Carcinoma
Stage IIIA Uterine Corpus Cancer AJCC v7
Stage IIIB Uterine Corpus Cancer AJCC v7
Stage IIIC Uterine Corpus Cancer AJCC v7
Stage IVA Uterine Corpus Cancer AJCC v7
Stage IVB Uterine Corpus Cancer AJCC v7
Interventions Drug: Carboplatin
Drug: Cisplatin
Drug: Doxorubicin Hydrochloride
Biological: Filgrastim
Other: Laboratory Biomarker Analysis
Drug: Paclitaxel
Biological: Pegfilgrastim
Other: Quality-of-Life Assessment
Enrollment 1381
Recruitment Details GOG 0209 accrued 1381 patients from August 2003 to April 2009. 1312 of these patients were eligible.
Pre-assignment Details  
Arm/Group Title Doxorubicin, Cisplatin, Paclitaxel Paclitaxel, Carboplatin
Hide Arm/Group Description Patients receive doxorubicin IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 692 689
Completed 647 665
Not Completed 45 24
Reason Not Completed
Withdrawal by Subject             1             0
Ineligible             44             24
Arm/Group Title Arm I (Doxorubicin Hydrochloride, Cisplatin, Paclitaxel) Arm II (Paclitaxel, Carboplatin) Total
Hide Arm/Group Description Patients receive doxorubicin hydrochloride IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity. Total of all reporting groups
Overall Number of Baseline Participants 647 665 1312
Hide Baseline Analysis Population Description
Eligible and treated patients
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 647 participants 665 participants 1312 participants
<40 years
19
   2.9%
18
   2.7%
37
   2.8%
40 -49 years
67
  10.4%
70
  10.5%
137
  10.4%
50-59 years
192
  29.7%
219
  32.9%
411
  31.3%
60-60 years
256
  39.6%
244
  36.7%
500
  38.1%
>=70 years
113
  17.5%
114
  17.1%
227
  17.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 647 participants 665 participants 1312 participants
Female
647
 100.0%
665
 100.0%
1312
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Participants Alive at Time of Last Follow-up.
Hide Description The time alive in months from study entry to last contact or death.
Time Frame Patients were assessed during treatment. Following completion of treatment, follow up was assessed every 3 months for 2 years, then every 6 months for 3 years and annually after for a maximum of 10 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients. Data are reported from the second interim analysis.
Arm/Group Title Arm I (Doxorubicin, Cisplatin, Paclitaxel) Arm II (Paclitaxel, Carboplatin)
Hide Arm/Group Description:
Patients receive doxorubicin IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 647 665
Measure Type: Count of Participants
Unit of Measure: Participants
Alive
376
  58.1%
385
  57.9%
Dead
271
  41.9%
280
  42.1%
2.Secondary Outcome
Title Patient-reported Neurotoxicity (Ntx) as Measured by the FACT/GOG-Ntx Subscale (Short)
Hide Description The FACT/GOG-Ntx subscale (short version) contains 4 items measuring sensory neuropathy. Each item is scored using a 5-point Likert scale (0=not at all; 1= a little bit; 2=somewhat; 3=quite a bit; 4=very much). For east item, reversal was performed prior to score calculation so that a large score suggests less symptom. according to the FACIT measurement system, the subscale score was calculated as the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The Ntx subscale score ranges 0-16 with a large subscale score suggests less symptom or better QOL (Quality of Life).
Time Frame Baseline, 6 weeks post treatment start, 15 weeks post treatment start and 26 weeks post treatment start
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and evaluable and enrolled prior to 3/26/2006
Arm/Group Title Doxorubicin, Cisplatin, Paclitaxel Paclitaxel, Carboplatin
Hide Arm/Group Description:
Patients receive doxorubicin IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 228 246
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 14.9  (0.15) 14.9  (0.14)
6 Weeks 13.5  (0.28) 11.3  (0.27)
15 Weeks 11.1  (0.37) 11.2  (0.34)
26 Weeks 9.5  (0.41) 10.9  (0.36)
3.Secondary Outcome
Title Patient Reported Quality of Life as Measured With the Combination of Physical Well-being (PWB) Subscale and Functional Well-being (FWB) Subscale From the FACT-G
Hide Description The FACT-G contains 4 subscales: Physical Well Being (7 items), Social Well Being (7 items), Emotional Well Being (6 items), Functional Well Being (7 items). The combination (14 items) of the physical well-being (PWB) and functional well-being (FWB) subscales was used to measure the HRQOL (Health Related Quality of Life). Each item is scored using a 5-point Likert scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). for each negative item, reversal was performed prior to score calculation so that a large score suggests better QOL. A subscale score was calculated as the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answred item scores by the number of items in the subscale. The QOL was measured with the summation of the PWB and FWBsubscale score and ranges 0-56 with a large score suggests better QOL.
Time Frame Pre-treatment, 6 weeks post starting treatment (prior to cycle 3), 15 weeks post starting treatment (prior to cycle 6), 26 weeks post starting treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and evaluable and enrolled prior to 3/26/2006
Arm/Group Title Arm I (Doxorubicin, Cisplatin, Paclitaxel) Arm II (Paclitaxel, Carboplatin)
Hide Arm/Group Description:
Patients receive doxorubicin IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 228 246
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 39.4  (0.72) 37.9  (0.7)
6 weeks 35.5  (0.73) 37.5  (0.68)
15 weeks 35.3  (0.74) 36.5  (0.7)
26 weeks 39.8  (0.8) 38.5  (0.81)
4.Secondary Outcome
Title Number of Participants Alive at Time of Last Follow-up by Estrogen or Progesterone Receptor Status (Positive or Negative)
Hide Description The time alive in months from study entry to last contact or death.
Time Frame Patients were assessed during treatment. Following completion of treatment, follow up was assessed every 3 months for 2 years, then every 6 months for 3 years and annually thereafter, for a maximum of 10 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients with estrogen and progesterone receptor data.
Arm/Group Title Estrogen Receptor Positive Estrogen Receptor Negative Progesterone Receptor Positive Progesterone Receptor Negative
Hide Arm/Group Description:
Patients with estrogen receptor positive tumors
Patients with estrogen receptor negative tumors
Patients with progesterone receptor positive tumors
Patients with progesterone receptor negative tumors
Overall Number of Participants Analyzed 919 355 832 440
Measure Type: Count of Participants
Unit of Measure: Participants
Alive
408
  44.4%
90
  25.4%
380
  45.7%
117
  26.6%
Dead
511
  55.6%
265
  74.6%
452
  54.3%
323
  73.4%
5.Secondary Outcome
Title Number of Participants With Indicated Severity of CTCAE v2 Graded Neurotoxicity and Infection
Hide Description Maximum grade of physician assessed neurotoxicity and infection
Time Frame Assessed throughout the treatment period and for 30 days after discontinuation of treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients
Arm/Group Title Arm I (Doxorubicin Hydrochloride, Cisplatin, Paclitaxel) Arm II (Paclitaxel, Carboplatin)
Hide Arm/Group Description:
Patients receive doxorubicin hydrochloride IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 640 664
Measure Type: Count of Participants
Unit of Measure: Participants
Grade < 2 Sensory neuropathy
167
  26.1%
130
  19.6%
Grade 2 or Higher Sensory Neuropathy
473
  73.9%
534
  80.4%
Grade <3 infection with Neutrope
25
   3.9%
29
   4.4%
Grade 3 or Higher Infection with Neutropenia
615
  96.1%
635
  95.6%
Grade <3 infection without Neutropenia
22
   3.4%
13
   2.0%
Grade 3 or Higher Infection without Neutropenia
618
  96.6%
651
  98.0%
Time Frame Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years.
Adverse Event Reporting Description CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
 
Arm/Group Title Arm I (Doxorubicin, Cisplatin, Paclitaxel) Arm II (Paclitaxel, Carboplatin)
Hide Arm/Group Description Patients receive doxorubicin IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Arm I (Doxorubicin, Cisplatin, Paclitaxel) Arm II (Paclitaxel, Carboplatin)
Affected / at Risk (%) Affected / at Risk (%)
Total   271/647 (41.89%)   280/665 (42.11%) 
Hide Serious Adverse Events
Arm I (Doxorubicin, Cisplatin, Paclitaxel) Arm II (Paclitaxel, Carboplatin)
Affected / at Risk (%) Affected / at Risk (%)
Total   217/647 (33.54%)   156/665 (23.46%) 
Blood and lymphatic system disorders     
Hemoglobin * 1  5/647 (0.77%)  10/665 (1.50%) 
Hematologic-Other * 1  0/647 (0.00%)  1/665 (0.15%) 
Transfusion: Platelets * 1  1/647 (0.15%)  0/665 (0.00%) 
Transfusion: Prbcs * 1  2/647 (0.31%)  1/665 (0.15%) 
Platelets * 1  4/647 (0.62%)  5/665 (0.75%) 
Neutrophils/Granulocytes * 1  16/647 (2.47%)  26/665 (3.91%) 
Leukocytes * 1  5/647 (0.77%)  0/665 (0.00%) 
Lymphatics-Other * 1  1/647 (0.15%)  0/665 (0.00%) 
Cardiac disorders     
Hypertension * 1  1/647 (0.15%)  0/665 (0.00%) 
Circulatory Or Cardiac-Other * 1  1/647 (0.15%)  0/665 (0.00%) 
Cardiac Left Ventricular Function * 1  2/647 (0.31%)  1/665 (0.15%) 
Hypotension * 1  0/647 (0.00%)  2/665 (0.30%) 
Sinus Tachycardia * 1  1/647 (0.15%)  0/665 (0.00%) 
Phlebitis * 1  1/647 (0.15%)  0/665 (0.00%) 
Vasovagal Episode * 1  0/647 (0.00%)  1/665 (0.15%) 
Supraventricular Arrhythmias * 1  2/647 (0.31%)  1/665 (0.15%) 
Thrombosis/Embolism * 1  33/647 (5.10%)  16/665 (2.41%) 
Cardiac-Ischemia/Infarction * 1  3/647 (0.46%)  0/665 (0.00%) 
Sinus Bradycardia * 1  1/647 (0.15%)  0/665 (0.00%) 
Eye disorders     
Ocular-Other * 1  0/647 (0.00%)  1/665 (0.15%) 
Gastrointestinal disorders     
Stomatitis/Pharyngitis * 1  1/647 (0.15%)  0/665 (0.00%) 
Gi-Other * 1  5/647 (0.77%)  3/665 (0.45%) 
Fistula-Intestinal * 1  1/647 (0.15%)  1/665 (0.15%) 
Duodenal Ulcer * 1  0/647 (0.00%)  1/665 (0.15%) 
Ileus * 1  3/647 (0.46%)  3/665 (0.45%) 
Gastritis * 1  0/647 (0.00%)  1/665 (0.15%) 
Mucositis Due To Radiation * 1  0/647 (0.00%)  1/665 (0.15%) 
Colitis * 1  0/647 (0.00%)  2/665 (0.30%) 
Fistula-Rectal/Anal * 1  1/647 (0.15%)  1/665 (0.15%) 
Dehydration * 1  16/647 (2.47%)  9/665 (1.35%) 
Constipation * 1  2/647 (0.31%)  4/665 (0.60%) 
Diarrhea (Without Colostomy) * 1  9/647 (1.39%)  1/665 (0.15%) 
Vomiting * 1  13/647 (2.01%)  2/665 (0.30%) 
Nausea * 1  7/647 (1.08%)  3/665 (0.45%) 
General disorders     
Constitutional Symptoms-Other * 1  1/647 (0.15%)  1/665 (0.15%) 
Fever In The Absence Of Neutropenia * 1  2/647 (0.31%)  1/665 (0.15%) 
Fatigue * 1  5/647 (0.77%)  1/665 (0.15%) 
Chest Pain Non-Cardiac Or Non-Pleuritic * 1  1/647 (0.15%)  4/665 (0.60%) 
Rectal Or Perirectal Pain * 1  0/647 (0.00%)  1/665 (0.15%) 
Abdominal Pain Or Cramping * 1  6/647 (0.93%)  4/665 (0.60%) 
Pain-Other * 1  0/647 (0.00%)  1/665 (0.15%) 
Syndromes-Other * 1  0/647 (0.00%)  1/665 (0.15%) 
Hepatobiliary disorders     
Hepatic-Other * 1  0/647 (0.00%)  1/665 (0.15%) 
Sgot * 1  1/647 (0.15%)  1/665 (0.15%) 
Immune system disorders     
Allergic Reaction/Hypersensitivity * 1  4/647 (0.62%)  3/665 (0.45%) 
Infections and infestations     
Infection, Other * 1  3/647 (0.46%)  0/665 (0.00%) 
Catheter-Related Infection * 1  6/647 (0.93%)  1/665 (0.15%) 
Infection With Unknown Anc * 1  1/647 (0.15%)  1/665 (0.15%) 
Infection Documented W Grd 3/4 Neutropn. * 1  18/647 (2.78%)  9/665 (1.35%) 
Infection Without Neutropenia * 1  17/647 (2.63%)  8/665 (1.20%) 
Febrile Neutropenia-Fuo Infect Not Docum * 1  14/647 (2.16%)  14/665 (2.11%) 
Metabolism and nutrition disorders     
Hyponatremia * 1  3/647 (0.46%)  0/665 (0.00%) 
Hypocalcemia * 1  2/647 (0.31%)  0/665 (0.00%) 
Hyperglycemia * 1  1/647 (0.15%)  2/665 (0.30%) 
Hypokalemia * 1  5/647 (0.77%)  2/665 (0.30%) 
Hypomagnesmia * 1  4/647 (0.62%)  0/665 (0.00%) 
Musculoskeletal and connective tissue disorders     
Muscle Weakness Not Due To Neuropathy * 1  3/647 (0.46%)  1/665 (0.15%) 
Nervous system disorders     
Tremor * 1  1/647 (0.15%)  0/665 (0.00%) 
Neurologic-Other * 1  1/647 (0.15%)  2/665 (0.30%) 
Seizure(S) * 1  1/647 (0.15%)  0/665 (0.00%) 
Depressed Level Of Consciousness * 1  0/647 (0.00%)  1/665 (0.15%) 
Cns Cerebrovascular Ischemia * 1  3/647 (0.46%)  1/665 (0.15%) 
Confusion * 1  0/647 (0.00%)  1/665 (0.15%) 
Ataxia * 1  0/647 (0.00%)  2/665 (0.30%) 
Syncope * 1  1/647 (0.15%)  1/665 (0.15%) 
Mood Alteration-Anxiety Agitation * 1  0/647 (0.00%)  1/665 (0.15%) 
Mood Alteration-Depression * 1  3/647 (0.46%)  0/665 (0.00%) 
Neuropathy-Sensory * 1  2/647 (0.31%)  1/665 (0.15%) 
Neuropathy Motor * 1  0/647 (0.00%)  2/665 (0.30%) 
Renal and urinary disorders     
Ureteral Obstruction * 1  0/647 (0.00%)  3/665 (0.45%) 
Fistula Or Gu Fistula * 1  0/647 (0.00%)  1/665 (0.15%) 
Renal Failure * 1  0/647 (0.00%)  1/665 (0.15%) 
Creatinine * 1  4/647 (0.62%)  2/665 (0.30%) 
Renal/Gu-Other * 1  2/647 (0.31%)  1/665 (0.15%) 
Respiratory, thoracic and mediastinal disorders     
Pneumonitis/Pulmonary Infiltrates * 1  1/647 (0.15%)  0/665 (0.00%) 
Pleural Effusion (Non-Malignant) * 1  0/647 (0.00%)  1/665 (0.15%) 
Dyspnea * 1  3/647 (0.46%)  4/665 (0.60%) 
Pulmonary-Other * 1  3/647 (0.46%)  1/665 (0.15%) 
Pneumothorax * 1  1/647 (0.15%)  1/665 (0.15%) 
Hypoxia * 1  0/647 (0.00%)  1/665 (0.15%) 
Adult Respiratory Distress Syndrome * 1  1/647 (0.15%)  0/665 (0.00%) 
Skin and subcutaneous tissue disorders     
Wound-Infectious * 1  2/647 (0.31%)  3/665 (0.45%) 
Skin-Other * 1  1/647 (0.15%)  0/665 (0.00%) 
Wound-Non-Infectious * 1  1/647 (0.15%)  0/665 (0.00%) 
Vascular disorders     
Prothrombin Time * 1  1/647 (0.15%)  0/665 (0.00%) 
Melena/Gi Bleeding * 1  3/647 (0.46%)  1/665 (0.15%) 
Vaginal Bleeding * 1  2/647 (0.31%)  1/665 (0.15%) 
Rectal Bleeding/Hematochezia * 1  1/647 (0.15%)  0/665 (0.00%) 
Hemorrhage/Bleeding Without Grade 3 Or 4 * 1  1/647 (0.15%)  0/665 (0.00%) 
1
Term from vocabulary, CTCAE (2.0)
*
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 (Doxorubicin, Cisplatin, Paclitaxel) Arm II (Paclitaxel, Carboplatin)
Affected / at Risk (%) Affected / at Risk (%)
Total   631/647 (97.53%)   657/665 (98.80%) 
Blood and lymphatic system disorders     
Leukocytes * 1  418/647 (64.61%)  556/665 (83.61%) 
Neutrophils/Granulocytes * 1  402/647 (62.13%)  590/665 (88.72%) 
Platelets * 1  244/647 (37.71%)  172/665 (25.86%) 
Hemoglobin * 1  445/647 (68.78%)  410/665 (61.65%) 
Hematologic-Other * 1  202/647 (31.22%)  156/665 (23.46%) 
Blood and lymphatic system disorders * 1  7/647 (1.08%)  3/665 (0.45%) 
Cardiac disorders     
Cardiac Left Ventricular Function * 1  50/647 (7.73%)  0/665 (0.00%) 
Cardiac disorders * 1  55/647 (8.50%)  40/665 (6.02%) 
Ear and labyrinth disorders     
Ear and labyrinth disorders * 1  26/647 (4.02%)  13/665 (1.95%) 
Endocrine disorders     
Endocrine disorders * 1  11/647 (1.70%)  7/665 (1.05%) 
Eye disorders     
Eye disorders * 1  46/647 (7.11%)  34/665 (5.11%) 
Gastrointestinal disorders     
All other GI * 1  163/647 (25.19%)  125/665 (18.80%) 
Nausea * 1  218/647 (33.69%)  122/665 (18.35%) 
Vomiting * 1  165/647 (25.50%)  82/665 (12.33%) 
Stomatitis/Pharyngitis * 1  54/647 (8.35%)  17/665 (2.56%) 
General disorders     
Constitutional * 1  37/647 (5.72%)  26/665 (3.91%) 
Pain * 1  91/647 (14.06%)  89/665 (13.38%) 
myalgia * 1  95/647 (14.68%)  97/665 (14.59%) 
Hepatobiliary disorders     
Hepatobiliary disorders * 1  17/647 (2.63%)  17/665 (2.56%) 
Immune system disorders     
Allergic Reaction/Hypersensitivity * 1  18/647 (2.78%)  29/665 (4.36%) 
Infections and infestations     
Infections and infestations * 1  19/647 (2.94%)  8/665 (1.20%) 
Febrile Neutropenia-Fuo Infect Not Docum * 1  45/647 (6.96%)  37/665 (5.56%) 
Infection Without Neutropenia * 1  54/647 (8.35%)  25/665 (3.76%) 
Metabolism and nutrition disorders     
Metabolism and nutrition disorders * 1  140/647 (21.64%)  96/665 (14.44%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal and connective tissue disorders * 1  24/647 (3.71%)  20/665 (3.01%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified (including cysts and polyps) * 1  1/647 (0.15%)  3/665 (0.45%) 
Nervous system disorders     
Nervous system disorders * 1  67/647 (10.36%)  47/665 (7.07%) 
Neuropathy: sensory * 1  163/647 (25.19%)  128/665 (19.25%) 
Renal and urinary disorders     
Renal and urinary disorders * 1  15/647 (2.32%)  20/665 (3.01%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory, thoracic and mediastinal disorders * 1  90/647 (13.91%)  82/665 (12.33%) 
Skin and subcutaneous tissue disorders     
Hair loss/alopecia (scalp or body) * 1  473/647 (73.11%)  486/665 (73.08%) 
Skin and subcutaneous tissue disorders * 1  25/647 (3.86%)  12/665 (1.80%) 
Vascular disorders     
Vascular disorders * 1  5/647 (0.77%)  4/665 (0.60%) 
Vascular disorders * 1  6/647 (0.93%)  7/665 (1.05%) 
1
Term from vocabulary, CTCAE (2.0)
*
Indicates events were collected by non-systematic assessment
Eligibility for this study was expanded from measurable, stage 3 or stage 4 or recurrent disease to include non-measurable, stage 4 or recurrent disease and then to include non-measurable stage 3 disease.
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: Linda Gedeon for Virginia Filiaci, PhD.
Organization: NRG Oncology
Phone: 716-545-8321
EMail: lgedeon@gogstats.org
Layout table for additonal information
Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00063999    
Other Study ID Numbers: GOG-0209
NCI-2009-00584 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000305940
GOG-0209 ( Other Identifier: NRG Oncology )
GOG-0209 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: July 8, 2003
First Posted: July 9, 2003
Results First Submitted: January 24, 2018
Results First Posted: April 23, 2018
Last Update Posted: May 28, 2019