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Gemcitabine Hydrochloride and Docetaxel With or Without Bevacizumab in Treating Patients With Advanced or Recurrent Uterine Leiomyosarcoma

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: NCT01012297
Recruitment Status : Terminated (The study was targeted to accrue 130 patients, but closed early for futility.)
First Posted : November 13, 2009
Results First Posted : July 14, 2017
Last Update Posted : September 2, 2020
Sponsor:
Collaborator:
NRG Oncology
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Recurrent Uterine Corpus Sarcoma
Stage IIIA Uterine Sarcoma
Stage IIIB Uterine Sarcoma
Stage IIIC Uterine Sarcoma
Stage IVA Uterine Sarcoma
Stage IVB Uterine Sarcoma
Uterine Corpus Leiomyosarcoma
Interventions Biological: Bevacizumab
Drug: Docetaxel
Biological: Filgrastim
Drug: Gemcitabine Hydrochloride
Biological: Pegfilgrastim
Other: Placebo
Enrollment 107
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I Gem+Doce+Placebo Arm II Gem+Doce+Bev
Hide Arm/Group Description

Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.

Docetaxel: Given IV

Filgrastim: Given SC

Gemcitabine Hydrochloride: Given IV

Pegfilgrastim: Given SC

Placebo: Given IV

Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10.

Bevacizumab: Given IV

Docetaxel: Given IV

Filgrastim: Given SC

Gemcitabine Hydrochloride: Given IV

Pegfilgrastim: Given SC

Period Title: Overall Study
Started 54 53
Completed 54 53
Not Completed 0 0
Arm/Group Title Arm I Gem+Doce+Placebo Arm II Gem+Doce+Bev Total
Hide Arm/Group Description

Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.

Docetaxel: Given IV

Filgrastim: Given SC

Gemcitabine Hydrochloride: Given IV

Pegfilgrastim: Given SC

Placebo: Given IV

Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10.

Bevacizumab: Given IV

Docetaxel: Given IV

Filgrastim: Given SC

Gemcitabine Hydrochloride: Given IV

Pegfilgrastim: Given SC

Total of all reporting groups
Overall Number of Baseline Participants 54 53 107
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 54 participants 53 participants 107 participants
57.5  (8.1) 54.0  (8.7) 55.7  (8.6)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Age Groups Number Analyzed 54 participants 53 participants 107 participants
20-29 years
0
   0.0%
1
   1.9%
1
   0.9%
30-39 years
0
   0.0%
3
   5.7%
3
   2.8%
40-49 years
11
  20.4%
12
  22.6%
23
  21.5%
50-59 years
24
  44.4%
25
  47.2%
49
  45.8%
60-69 years
19
  35.2%
12
  22.6%
31
  29.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 53 participants 107 participants
Female
54
 100.0%
53
 100.0%
107
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 53 participants 107 participants
Hispanic or Latino
4
   7.4%
3
   5.7%
7
   6.5%
Not Hispanic or Latino
48
  88.9%
43
  81.1%
91
  85.0%
Unknown or Not Reported
2
   3.7%
7
  13.2%
9
   8.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 53 participants 107 participants
American Indian or Alaska Native
0
   0.0%
1
   1.9%
1
   0.9%
Asian
1
   1.9%
1
   1.9%
2
   1.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
  11.1%
12
  22.6%
18
  16.8%
White
46
  85.2%
36
  67.9%
82
  76.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   1.9%
3
   5.7%
4
   3.7%
Prior whole pelvic radiation  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 53 participants 107 participants
Yes
11
  20.4%
11
  20.8%
22
  20.6%
No
43
  79.6%
42
  79.2%
85
  79.4%
Performance Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 53 participants 107 participants
0: Asymptomatic
38
  70.4%
41
  77.4%
79
  73.8%
1: Symptomatic, fully ambulatory
15
  27.8%
11
  20.8%
26
  24.3%
2: Symptomatic, in bed < 50% of time
1
   1.9%
1
   1.9%
2
   1.9%
FIGO Stage   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 53 participants 107 participants
1
20
  37.0%
11
  20.8%
31
  29.0%
2
4
   7.4%
0
   0.0%
4
   3.7%
3
3
   5.6%
5
   9.4%
8
   7.5%
4
22
  40.7%
30
  56.6%
52
  48.6%
unknown
5
   9.3%
7
  13.2%
12
  11.2%
[1]
Measure Description: FIGO Stage describes disease burden at time of surgery. Stage 1 indicates the cancer has not spread beyond the uterus. Stage 4 indicates cancer metastasis in distant organs.
Cell Type  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 53 participants 107 participants
Leiomyosarcoma
52
  96.3%
52
  98.1%
104
  97.2%
Sarcoma, Unsp.
1
   1.9%
0
   0.0%
1
   0.9%
Carcinsarcoma
0
   0.0%
1
   1.9%
1
   0.9%
Unknown
1
   1.9%
0
   0.0%
1
   0.9%
1.Primary Outcome
Title Progression-free Survival
Hide Description

Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last followup were censored on the date of last CT Scan.

Assessed with a log-rank test stratified by whether the patient had whole pelvic radiotherapy prior to starting the study treatment. The product-limit method will be used to estimate the cumulative distribution of PFS for the patients assigned to each treatment group.

Time Frame From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized
Arm/Group Title Arm I Gem+Doce+Placebo Arm II Gem+Doce+Bev
Hide Arm/Group Description:

Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.

Docetaxel: Given IV

Filgrastim: Given SC

Gemcitabine Hydrochloride: Given IV

Pegfilgrastim: Given SC

Placebo: Given IV

Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10.

Bevacizumab: Given IV

Docetaxel: Given IV

Filgrastim: Given SC

Gemcitabine Hydrochloride: Given IV

Pegfilgrastim: Given SC

Overall Number of Participants Analyzed 54 53
Median (95% Confidence Interval)
Unit of Measure: months
6.2
(2.9 to 9.9)
4.2
(3.1 to 8.4)
2.Secondary 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 followup were censored on the date of last CT Scan.

The product-limit method will be used to estimate the cumulative distribution of overall survival times for the patients assigned to each treatment group.

Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized
Arm/Group Title Arm I Gem+Doce+Placebo Arm II Gem+Doce+Bev
Hide Arm/Group Description:

Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.

Docetaxel: Given IV

Filgrastim: Given SC

Gemcitabine Hydrochloride: Given IV

Pegfilgrastim: Given SC

Placebo: Given IV

Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10.

Bevacizumab: Given IV

Docetaxel: Given IV

Filgrastim: Given SC

Gemcitabine Hydrochloride: Given IV

Pegfilgrastim: Given SC

Overall Number of Participants Analyzed 54 53
Median (95% Confidence Interval)
Unit of Measure: months
26.9
(15.9 to 32.1)
23.3
(16.6 to 27.3)
3.Secondary Outcome
Title Frequency and Severity of Adverse Effects as Assessed by the CTCAE Version 4.0
Hide Description

Count of participants with Adverse events (AEs) that are CTCAE Grade 3 or worse.

Please refer to the adverse event reporting for more detail.

Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized.
Arm/Group Title Arm I Gem+Doce+Placebo Arm II Gem+Doce+Bev
Hide Arm/Group Description:

Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.

Docetaxel: Given IV

Filgrastim: Given SC

Gemcitabine Hydrochloride: Given IV

Pegfilgrastim: Given SC

Placebo: Given IV

Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10.

Bevacizumab: Given IV

Docetaxel: Given IV

Filgrastim: Given SC

Gemcitabine Hydrochloride: Given IV

Pegfilgrastim: Given SC

Overall Number of Participants Analyzed 54 53
Measure Type: Count of Participants
Unit of Measure: Participants
36
  66.7%
46
  86.8%
4.Secondary Outcome
Title Objective Response Rate as Measured by RECIST 1.1 Criteria
Hide Description "Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized
Arm/Group Title Arm I Gem+Doce+Placebo Arm II Gem+Doce+Bev
Hide Arm/Group Description:

Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.

Docetaxel: Given IV

Filgrastim: Given SC

Gemcitabine Hydrochloride: Given IV

Pegfilgrastim: Given SC

Placebo: Given IV

Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10.

Bevacizumab: Given IV

Docetaxel: Given IV

Filgrastim: Given SC

Gemcitabine Hydrochloride: Given IV

Pegfilgrastim: Given SC

Overall Number of Participants Analyzed 54 53
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
31.5
(21.2 to 43.4)
35.8
(24.9 to 48.0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I Arm II
Hide Arm/Group Description

Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.

Docetaxel: Given IV

Filgrastim: Given SC

Gemcitabine Hydrochloride: Given IV

Pegfilgrastim: Given SC

Placebo: Given IV

Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10.

Bevacizumab: Given IV

Docetaxel: Given IV

Filgrastim: Given SC

Gemcitabine Hydrochloride: Given IV

Pegfilgrastim: Given SC

All-Cause Mortality
Arm I Arm II
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Arm I Arm II
Affected / at Risk (%) Affected / at Risk (%)
Total   17/54 (31.48%)   21/53 (39.62%) 
Cardiac disorders     
Pericardial Effusion  0/54 (0.00%)  1/53 (1.89%) 
Gastrointestinal disorders     
Diarrhea  0/54 (0.00%)  1/53 (1.89%) 
Small Intestinal Obstruction  1/54 (1.85%)  2/53 (3.77%) 
Abdominal Pain  1/54 (1.85%)  2/53 (3.77%) 
General disorders     
Fatigue  2/54 (3.70%)  0/53 (0.00%) 
Immune system disorders     
Anaphylaxis  0/54 (0.00%)  1/53 (1.89%) 
Allergic Reaction  1/54 (1.85%)  0/53 (0.00%) 
Infections and infestations     
Infections And Infestations - Other  0/54 (0.00%)  2/53 (3.77%) 
Soft Tissue Infection  1/54 (1.85%)  0/53 (0.00%) 
Skin Infection  1/54 (1.85%)  0/53 (0.00%) 
Sepsis  1/54 (1.85%)  0/53 (0.00%) 
Lung Infection  3/54 (5.56%)  2/53 (3.77%) 
Catheter Related Infection  1/54 (1.85%)  2/53 (3.77%) 
Abdominal Infection  1/54 (1.85%)  0/53 (0.00%) 
Injury, poisoning and procedural complications     
Spinal Fracture  0/54 (0.00%)  1/53 (1.89%) 
Hip Fracture  1/54 (1.85%)  0/53 (0.00%) 
Fracture  1/54 (1.85%)  0/53 (0.00%) 
Investigations     
Platelet Count Decreased  1/54 (1.85%)  3/53 (5.66%) 
Lymphocyte Count Decreased  0/54 (0.00%)  1/53 (1.89%) 
Neutrophil Count Decreased  0/54 (0.00%)  1/53 (1.89%) 
Metabolism and nutrition disorders     
Hyperkalemia  1/54 (1.85%)  0/53 (0.00%) 
Hyperglycemia  2/54 (3.70%)  1/53 (1.89%) 
Dehydration  2/54 (3.70%)  1/53 (1.89%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory Failure  1/54 (1.85%)  0/53 (0.00%) 
Pneumonitis  0/54 (0.00%)  1/53 (1.89%) 
Dyspnea  0/54 (0.00%)  1/53 (1.89%) 
Vascular disorders     
Thromboembolic Event  2/54 (3.70%)  3/53 (5.66%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I Arm II
Affected / at Risk (%) Affected / at Risk (%)
Total   51/54 (94.44%)   51/53 (96.23%) 
Blood and lymphatic system disorders     
Thrombotic Thrombocytopenic Purpura  0/54 (0.00%)  1/53 (1.89%) 
Blood And Lymphatic System Disorders - Other  1/54 (1.85%)  2/53 (3.77%) 
Anemia  47/54 (87.04%)  48/53 (90.57%) 
Cardiac disorders     
Palpitations  2/54 (3.70%)  3/53 (5.66%) 
Pericardial Effusion  1/54 (1.85%)  1/53 (1.89%) 
Sinus Tachycardia  3/54 (5.56%)  5/53 (9.43%) 
Chest Pain - Cardiac  1/54 (1.85%)  0/53 (0.00%) 
Ear and labyrinth disorders     
Vertigo  1/54 (1.85%)  1/53 (1.89%) 
Tinnitus  2/54 (3.70%)  1/53 (1.89%) 
Hearing Impaired  0/54 (0.00%)  1/53 (1.89%) 
Ear Pain  1/54 (1.85%)  4/53 (7.55%) 
Eye disorders     
Eye Disorders - Other  1/54 (1.85%)  2/53 (3.77%) 
Watering Eyes  1/54 (1.85%)  9/53 (16.98%) 
Eye Pain  0/54 (0.00%)  1/53 (1.89%) 
Conjunctivitis  1/54 (1.85%)  1/53 (1.89%) 
Blurred Vision  6/54 (11.11%)  4/53 (7.55%) 
Dry Eye  1/54 (1.85%)  2/53 (3.77%) 
Gastrointestinal disorders     
Dysphagia  3/54 (5.56%)  3/53 (5.66%) 
Dyspepsia  6/54 (11.11%)  3/53 (5.66%) 
Dry Mouth  1/54 (1.85%)  5/53 (9.43%) 
Colitis  1/54 (1.85%)  0/53 (0.00%) 
Constipation  24/54 (44.44%)  26/53 (49.06%) 
Diarrhea  19/54 (35.19%)  22/53 (41.51%) 
Vomiting  14/54 (25.93%)  16/53 (30.19%) 
Bloating  1/54 (1.85%)  3/53 (5.66%) 
Stomach Pain  1/54 (1.85%)  1/53 (1.89%) 
Small Intestinal Obstruction  0/54 (0.00%)  2/53 (3.77%) 
Anal Hemorrhage  1/54 (1.85%)  2/53 (3.77%) 
Rectal Fistula  0/54 (0.00%)  1/53 (1.89%) 
Rectal Mucositis  1/54 (1.85%)  0/53 (0.00%) 
Abdominal Pain  16/54 (29.63%)  15/53 (28.30%) 
Rectal Hemorrhage  5/54 (9.26%)  2/53 (3.77%) 
Oral Dysesthesia  2/54 (3.70%)  1/53 (1.89%) 
Mucositis Oral  14/54 (25.93%)  15/53 (28.30%) 
Gastrointestinal Disorders - Other  1/54 (1.85%)  3/53 (5.66%) 
Oral Hemorrhage  0/54 (0.00%)  4/53 (7.55%) 
Gastrointestinal Pain  1/54 (1.85%)  1/53 (1.89%) 
Gingival Pain  1/54 (1.85%)  1/53 (1.89%) 
Oral Pain  2/54 (3.70%)  3/53 (5.66%) 
Abdominal Distension  5/54 (9.26%)  1/53 (1.89%) 
Nausea  35/54 (64.81%)  29/53 (54.72%) 
Gastroesophageal Reflux Disease  2/54 (3.70%)  6/53 (11.32%) 
Rectal Pain  0/54 (0.00%)  1/53 (1.89%) 
Esophagitis  1/54 (1.85%)  0/53 (0.00%) 
Hemorrhoidal Hemorrhage  3/54 (5.56%)  3/53 (5.66%) 
Hemorrhoids  1/54 (1.85%)  1/53 (1.89%) 
Ascites  0/54 (0.00%)  1/53 (1.89%) 
Toothache  1/54 (1.85%)  0/53 (0.00%) 
Esophageal Pain  1/54 (1.85%)  1/53 (1.89%) 
Flatulence  0/54 (0.00%)  1/53 (1.89%) 
General disorders     
General Disorders And Administration Site Conditio  2/54 (3.70%)  0/53 (0.00%) 
Pain  13/54 (24.07%)  9/53 (16.98%) 
Localized Edema  0/54 (0.00%)  1/53 (1.89%) 
Injection Site Reaction  2/54 (3.70%)  2/53 (3.77%) 
Infusion Site Extravasation  1/54 (1.85%)  0/53 (0.00%) 
Flu Like Symptoms  2/54 (3.70%)  2/53 (3.77%) 
Edema Trunk  2/54 (3.70%)  0/53 (0.00%) 
Non-Cardiac Chest Pain  4/54 (7.41%)  3/53 (5.66%) 
Edema Limbs  23/54 (42.59%)  12/53 (22.64%) 
Edema Face  4/54 (7.41%)  3/53 (5.66%) 
Fatigue  45/54 (83.33%)  42/53 (79.25%) 
Fever  17/54 (31.48%)  19/53 (35.85%) 
Chills  3/54 (5.56%)  3/53 (5.66%) 
Infusion Related Reaction  2/54 (3.70%)  1/53 (1.89%) 
Hepatobiliary disorders     
Cholecystitis  0/54 (0.00%)  1/53 (1.89%) 
Immune system disorders     
Allergic Reaction  7/54 (12.96%)  1/53 (1.89%) 
Cytokine Release Syndrome  1/54 (1.85%)  0/53 (0.00%) 
Infections and infestations     
Infections And Infestations - Other  2/54 (3.70%)  1/53 (1.89%) 
Upper Respiratory Infection  2/54 (3.70%)  1/53 (1.89%) 
Tooth Infection  1/54 (1.85%)  3/53 (5.66%) 
Skin Infection  2/54 (3.70%)  0/53 (0.00%) 
Sinusitis  2/54 (3.70%)  1/53 (1.89%) 
Papulopustular Rash  1/54 (1.85%)  0/53 (0.00%) 
Nail Infection  1/54 (1.85%)  3/53 (5.66%) 
Mucosal Infection  3/54 (5.56%)  1/53 (1.89%) 
Pelvic Infection  0/54 (0.00%)  1/53 (1.89%) 
Lung Infection  2/54 (3.70%)  2/53 (3.77%) 
Eye Infection  0/54 (0.00%)  1/53 (1.89%) 
Device Related Infection  2/54 (3.70%)  1/53 (1.89%) 
Vaginal Infection  1/54 (1.85%)  0/53 (0.00%) 
Urinary Tract Infection  8/54 (14.81%)  7/53 (13.21%) 
Catheter Related Infection  0/54 (0.00%)  2/53 (3.77%) 
Bronchial Infection  1/54 (1.85%)  0/53 (0.00%) 
Enterocolitis Infectious  1/54 (1.85%)  0/53 (0.00%) 
Bladder Infection  0/54 (0.00%)  1/53 (1.89%) 
Lip Infection  1/54 (1.85%)  0/53 (0.00%) 
Anorectal Infection  0/54 (0.00%)  1/53 (1.89%) 
Injury, poisoning and procedural complications     
Injury, Poisoning And Procedural Complications - O  1/54 (1.85%)  0/53 (0.00%) 
Vascular Access Complication  0/54 (0.00%)  1/53 (1.89%) 
Tracheostomy Site Bleeding  1/54 (1.85%)  0/53 (0.00%) 
Fall  1/54 (1.85%)  0/53 (0.00%) 
Bruising  2/54 (3.70%)  4/53 (7.55%) 
Ankle Fracture  1/54 (1.85%)  0/53 (0.00%) 
Investigations     
Investigations - Other  2/54 (3.70%)  0/53 (0.00%) 
Weight Loss  4/54 (7.41%)  6/53 (11.32%) 
Weight Gain  4/54 (7.41%)  5/53 (9.43%) 
Platelet Count Decreased  39/54 (72.22%)  45/53 (84.91%) 
Lymphocyte Count Decreased  2/54 (3.70%)  5/53 (9.43%) 
Inr Increased  2/54 (3.70%)  0/53 (0.00%) 
Creatinine Increased  2/54 (3.70%)  3/53 (5.66%) 
Neutrophil Count Decreased  26/54 (48.15%)  25/53 (47.17%) 
Blood Bilirubin Increased  2/54 (3.70%)  1/53 (1.89%) 
White Blood Cell Decreased  28/54 (51.85%)  33/53 (62.26%) 
Aspartate Aminotransferase Increased  9/54 (16.67%)  10/53 (18.87%) 
Alkaline Phosphatase Increased  16/54 (29.63%)  17/53 (32.08%) 
Alanine Aminotransferase Increased  14/54 (25.93%)  10/53 (18.87%) 
Activated Partial Thromboplastin Time Prolonged  2/54 (3.70%)  1/53 (1.89%) 
Metabolism and nutrition disorders     
Metabolism And Nutrition Disorders - Other  2/54 (3.70%)  1/53 (1.89%) 
Hypophosphatemia  1/54 (1.85%)  2/53 (3.77%) 
Hyponatremia  8/54 (14.81%)  5/53 (9.43%) 
Hypomagnesemia  6/54 (11.11%)  4/53 (7.55%) 
Hypokalemia  8/54 (14.81%)  8/53 (15.09%) 
Hypoglycemia  1/54 (1.85%)  1/53 (1.89%) 
Hypocalcemia  12/54 (22.22%)  8/53 (15.09%) 
Hypoalbuminemia  14/54 (25.93%)  9/53 (16.98%) 
Hypernatremia  1/54 (1.85%)  1/53 (1.89%) 
Hypermagnesemia  2/54 (3.70%)  1/53 (1.89%) 
Hyperkalemia  2/54 (3.70%)  3/53 (5.66%) 
Hyperglycemia  14/54 (25.93%)  7/53 (13.21%) 
Hypercalcemia  0/54 (0.00%)  5/53 (9.43%) 
Dehydration  3/54 (5.56%)  2/53 (3.77%) 
Anorexia  21/54 (38.89%)  19/53 (35.85%) 
Musculoskeletal and connective tissue disorders     
Pain In Extremity  13/54 (24.07%)  12/53 (22.64%) 
Neck Pain  2/54 (3.70%)  1/53 (1.89%) 
Myalgia  11/54 (20.37%)  20/53 (37.74%) 
Musculoskeletal Deformity  0/54 (0.00%)  1/53 (1.89%) 
Muscle Weakness Upper Limb  0/54 (0.00%)  1/53 (1.89%) 
Muscle Weakness Lower Limb  2/54 (3.70%)  2/53 (3.77%) 
Joint Range Of Motion Decreased  0/54 (0.00%)  1/53 (1.89%) 
Generalized Muscle Weakness  5/54 (9.26%)  3/53 (5.66%) 
Flank Pain  2/54 (3.70%)  0/53 (0.00%) 
Chest Wall Pain  1/54 (1.85%)  4/53 (7.55%) 
Buttock Pain  0/54 (0.00%)  2/53 (3.77%) 
Bone Pain  13/54 (24.07%)  11/53 (20.75%) 
Back Pain  9/54 (16.67%)  9/53 (16.98%) 
Arthritis  1/54 (1.85%)  0/53 (0.00%) 
Arthralgia  10/54 (18.52%)  9/53 (16.98%) 
Musculoskeletal And Connective Tissue Disorder -  1/54 (1.85%)  1/53 (1.89%) 
Nervous system disorders     
Tremor  1/54 (1.85%)  0/53 (0.00%) 
Spasticity  0/54 (0.00%)  1/53 (1.89%) 
Seizure  1/54 (1.85%)  0/53 (0.00%) 
Peripheral Sensory Neuropathy  21/54 (38.89%)  19/53 (35.85%) 
Peripheral Motor Neuropathy  3/54 (5.56%)  3/53 (5.66%) 
Paresthesia  2/54 (3.70%)  3/53 (5.66%) 
Memory Impairment  1/54 (1.85%)  0/53 (0.00%) 
Lethargy  1/54 (1.85%)  0/53 (0.00%) 
Headache  17/54 (31.48%)  14/53 (26.42%) 
Dysgeusia  6/54 (11.11%)  8/53 (15.09%) 
Sinus Pain  0/54 (0.00%)  1/53 (1.89%) 
Syncope  1/54 (1.85%)  0/53 (0.00%) 
Dizziness  9/54 (16.67%)  7/53 (13.21%) 
Ataxia  1/54 (1.85%)  1/53 (1.89%) 
Psychiatric disorders     
Restlessness  0/54 (0.00%)  1/53 (1.89%) 
Insomnia  11/54 (20.37%)  10/53 (18.87%) 
Depression  5/54 (9.26%)  7/53 (13.21%) 
Anxiety  10/54 (18.52%)  9/53 (16.98%) 
Renal and urinary disorders     
Renal And Urinary Disorders - Other  2/54 (3.70%)  0/53 (0.00%) 
Urinary Retention  2/54 (3.70%)  0/53 (0.00%) 
Urinary Incontinence  0/54 (0.00%)  4/53 (7.55%) 
Urinary Tract Pain  2/54 (3.70%)  1/53 (1.89%) 
Urinary Frequency  0/54 (0.00%)  2/53 (3.77%) 
Proteinuria  2/54 (3.70%)  1/53 (1.89%) 
Hemoglobinuria  1/54 (1.85%)  0/53 (0.00%) 
Hematuria  2/54 (3.70%)  2/53 (3.77%) 
Cystitis Noninfective  1/54 (1.85%)  0/53 (0.00%) 
Bladder Spasm  0/54 (0.00%)  1/53 (1.89%) 
Reproductive system and breast disorders     
Reproductive System And Breast Disorders - Other  0/54 (0.00%)  1/53 (1.89%) 
Vaginal Pain  0/54 (0.00%)  1/53 (1.89%) 
Vaginal Hemorrhage  0/54 (0.00%)  1/53 (1.89%) 
Pelvic Pain  2/54 (3.70%)  1/53 (1.89%) 
Vaginal Discharge  0/54 (0.00%)  3/53 (5.66%) 
Breast Pain  1/54 (1.85%)  0/53 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Sore Throat  6/54 (11.11%)  9/53 (16.98%) 
Sneezing  0/54 (0.00%)  2/53 (3.77%) 
Sinus Disorder  0/54 (0.00%)  2/53 (3.77%) 
Postnasal Drip  1/54 (1.85%)  4/53 (7.55%) 
Pneumothorax  0/54 (0.00%)  1/53 (1.89%) 
Pneumonitis  2/54 (3.70%)  0/53 (0.00%) 
Pleural Effusion  2/54 (3.70%)  1/53 (1.89%) 
Pharyngeal Hemorrhage  0/54 (0.00%)  1/53 (1.89%) 
Nasal Congestion  6/54 (11.11%)  8/53 (15.09%) 
Productive Cough  0/54 (0.00%)  3/53 (5.66%) 
Laryngeal Inflammation  0/54 (0.00%)  1/53 (1.89%) 
Hypoxia  0/54 (0.00%)  1/53 (1.89%) 
Hoarseness  0/54 (0.00%)  6/53 (11.32%) 
Sleep Apnea  1/54 (1.85%)  0/53 (0.00%) 
Epistaxis  12/54 (22.22%)  25/53 (47.17%) 
Dyspnea  28/54 (51.85%)  23/53 (43.40%) 
Cough  14/54 (25.93%)  20/53 (37.74%) 
Bronchospasm  0/54 (0.00%)  1/53 (1.89%) 
Bronchopulmonary Hemorrhage  0/54 (0.00%)  1/53 (1.89%) 
Allergic Rhinitis  4/54 (7.41%)  5/53 (9.43%) 
Skin and subcutaneous tissue disorders     
Skin And Subcutaneous Tissue Disorders - Other  5/54 (9.26%)  4/53 (7.55%) 
Skin Ulceration  0/54 (0.00%)  1/53 (1.89%) 
Skin Hyperpigmentation  0/54 (0.00%)  5/53 (9.43%) 
Rash Acneiform  5/54 (9.26%)  7/53 (13.21%) 
Pruritus  0/54 (0.00%)  4/53 (7.55%) 
Periorbital Edema  0/54 (0.00%)  2/53 (3.77%) 
Palmar-Plantar Erythrodysesthesia Syndrome  1/54 (1.85%)  2/53 (3.77%) 
Pain Of Skin  1/54 (1.85%)  2/53 (3.77%) 
Rash Maculo-Papular  8/54 (14.81%)  5/53 (9.43%) 
Nail Ridging  1/54 (1.85%)  1/53 (1.89%) 
Nail Loss  3/54 (5.56%)  3/53 (5.66%) 
Nail Discoloration  2/54 (3.70%)  6/53 (11.32%) 
Hyperhidrosis  0/54 (0.00%)  3/53 (5.66%) 
Erythroderma  0/54 (0.00%)  1/53 (1.89%) 
Erythema Multiforme  1/54 (1.85%)  1/53 (1.89%) 
Dry Skin  0/54 (0.00%)  7/53 (13.21%) 
Body Odor  1/54 (1.85%)  0/53 (0.00%) 
Alopecia  36/54 (66.67%)  34/53 (64.15%) 
Vascular disorders     
Vascular Disorders - Other  0/54 (0.00%)  1/53 (1.89%) 
Thromboembolic Event  6/54 (11.11%)  4/53 (7.55%) 
Superficial Thrombophlebitis  0/54 (0.00%)  1/53 (1.89%) 
Lymphedema  0/54 (0.00%)  4/53 (7.55%) 
Hypotension  1/54 (1.85%)  1/53 (1.89%) 
Hypertension  10/54 (18.52%)  12/53 (22.64%) 
Hot Flashes  2/54 (3.70%)  7/53 (13.21%) 
Hematoma  1/54 (1.85%)  1/53 (1.89%) 
Flushing  1/54 (1.85%)  2/53 (3.77%) 
The study was targeted to accrue 130 patients, but closed early for futility. Early termination leading to small numbers of subjects analyzed.
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: Angela M. Kuras, Associate Director of Administration and Operations
Organization: NRG Oncology Statistics and Data Management Center - Buffalo
Phone: (716) 845-5702
EMail: kurasa@nrgoncology.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01012297    
Other Study ID Numbers: NCI-2010-01738
NCI-2010-01738 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000659024
GOG-0250
GOG-0250 ( Other Identifier: NRG Oncology )
GOG-0250 ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: November 12, 2009
First Posted: November 13, 2009
Results First Submitted: January 26, 2017
Results First Posted: July 14, 2017
Last Update Posted: September 2, 2020