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Trial record 14 of 526 for:    "Primary Peritoneal Carcinoma"

Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer or Primary Peritoneal 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: NCT00011986
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : April 19, 2016
Last Update Posted : April 16, 2019
Sponsor:
Collaborators:
Southwest Oncology Group
Medical Research Council
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 Primary Peritoneal Carcinoma
Stage III Ovarian Cancer
Stage IV Ovarian Cancer
Interventions Drug: Paclitaxel
Drug: Carboplatin
Drug: Gemcitabine Hydrochloride
Drug: Pegylated Liposomal Doxorubicin Hydrochloride
Drug: Topotecan Hydrochloride
Procedure: Therapeutic Conventional Surgery
Enrollment 4312
Recruitment Details Received began 1/29/2001 and ended 1/28/2003. This was an interventional trial involving patients enrolled from the United States (US), Canada, United Kingdom (UK), Italy, Australia, and New Zealand.
Pre-assignment Details This study involved patients enrolled from two cooperative groups with the plan to combine data. 3882 patients were enrolled from one cooperative group and 430 from the other. This report includes those patients from both groups.
Arm/Group Title Carbo/Taxol Carbo/Taxol/Gemcitabine Carbo/Taxol/Doxil Carbo/Topotecan - Carbo/Taxol Carbo/Gemcitabine - Carbo/Taxol
Hide Arm/Group Description Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Gemcitabine 800 mg/m2/dIV on days 1 and 8 x 8 cycles Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Doxil 30 mg/m2 IV every other cycle on day 1 x 8 cycles Topotecan 1.25 mg/m2/dIV days 1-3 plus Carboplatin AUC 5 IV on day 3 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles Gemcitabine 1000 mg/m2/dIV on days 1 and 8 plus Carboplatin AUC 6 IV on day 8 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
Period Title: Overall Study
Started 864 864 862 861 861
Initiated Treatment 862 860 854 846 851
Completed 864 864 862 861 861
Not Completed 0 0 0 0 0
Arm/Group Title Carbo/Taxol Carbo/Taxol/Gemcitabine Carbo/Taxol/Doxil Carbo/Topotecan - Carbo/Taxol Carbo/Gemcitabine - Carbo/Taxol Total
Hide Arm/Group Description Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Gemcitabine 800 mg/m2/dIV on days 1 and 8 x 8 cycles Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Doxil 30 mg/m2 IV every other cycle on day 1 x 8 cycles Topotecan 1.25 mg/m2/dIV days 1-3 plus Carboplatin AUC 5 IV on day 3 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles Gemcitabine 1000 mg/m2/dIV on days 1 and 8 plus Carboplatin AUC 6 IV on day 8 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles Total of all reporting groups
Overall Number of Baseline Participants 864 864 862 861 861 4312
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 864 participants 864 participants 862 participants 861 participants 861 participants 4312 participants
57.8  (11.1) 58.8  (10.8) 59.0  (11.1) 58.2  (11.0) 58.9  (10.7) 58.6  (10.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 864 participants 864 participants 862 participants 861 participants 861 participants 4312 participants
Female
864
 100.0%
864
 100.0%
862
 100.0%
861
 100.0%
861
 100.0%
4312
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
International Federation of Gynecology and Obstetrics (FIGO) Stage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 864 participants 864 participants 862 participants 861 participants 861 participants 4312 participants
Stage III:see description for details 724 749 743 744 721 3681
Stage IV:see description for details 140 115 119 117 140 631
[1]
Measure Description:

FIGO Staging Classification: 1985.

Stage III: Tumor involving one or both ovaries with peritoneal implants outside the pelvis and/or positive retroperitoneal or inguinal nodes. Superficial liver metastasis equals Stage III. Tumor is limited to the true pelvis but with histologically verified malignant extensions to small bowel or omentum.

Stage IV: Growth involving one or both ovaries with distant metastasis. If pleural effusion is present there must be positive cytologic test results to allot a case to Stage IV. Parenchymal liver metastasis equals Stage IV.

Primary Site of Disease  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 864 participants 864 participants 862 participants 861 participants 861 participants 4312 participants
Ovary 748 752 737 752 751 3740
Peritoneum 116 112 125 109 110 572
Size of Residual Disease  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 864 participants 864 participants 862 participants 861 participants 861 participants 4312 participants
Microscopic only 197 218 206 220 203 1044
≤ 1 cm gross disease 404 384 405 358 398 1949
> 1 cm gross disease 263 262 251 283 260 1319
1.Primary Outcome
Title Overall Survival
Hide Description Proportion of participants whose overall survival exceeded 5 years.
Time Frame Up to 9 years
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants.
Arm/Group Title Carbo/Taxol Carbo/Taxol/Gemcitabine Carbo/Taxol/Doxil Carbo/Topotecan - Carbo/Taxol Carbo/Gemcitabine - Carbo/Taxol
Hide Arm/Group Description:
Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles
Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Gemcitabine 800 mg/m2/dIV on days 1 and 8 x 8 cycles
Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Doxil 30 mg/m2 IV every other cycle on day 1 x 8 cycles
Topotecan 1.25 mg/m2/dIV days 1-3 plus Carboplatin AUC 5 IV on day 3 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
Gemcitabine 1000 mg/m2/dIV on days 1 and 8 plus Carboplatin AUC 6 IV on day 8 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
Overall Number of Participants Analyzed 864 864 862 861 861
Measure Type: Number
Unit of Measure: Proportion of participants
0.35 0.34 0.39 0.34 0.30
2.Primary Outcome
Title Progression-free Survival
Hide Description Median duration in months of progression free survival.
Time Frame From the date of enrollment to first progression or death or last contact, if alive and progression free.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Carbo/Taxol Carbo/Taxol/Gemcitabine Carbo/Taxol/Doxil Carbo/Topotecan - Carbo/Taxol Carbo/Gemcitabine - Carbo/Taxol
Hide Arm/Group Description:
Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles
Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Gemcitabine 800 mg/m2/dIV on days 1 and 8 x 8 cycles
Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Doxil 30 mg/m2 IV every other cycle on day 1 x 8 cycles
Topotecan 1.25 mg/m2/dIV days 1-3 plus Carboplatin AUC 5 IV on day 3 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
Gemcitabine 1000 mg/m2/dIV on days 1 and 8 plus Carboplatin AUC 6 IV on day 8 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
Overall Number of Participants Analyzed 864 864 862 861 861
Median (95% Confidence Interval)
Unit of Measure: months
16.0
(14.9 to 17.2)
16.3
(15.1 to 17.7)
16.4
(15.3 to 17.5)
15.4
(14.7 to 16.3)
15.4
(14.6 to 16.4)
3.Secondary Outcome
Title Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0
Hide Description [Not Specified]
Time Frame Up to 9 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated participants
Arm/Group Title Grade 3 and Above on ToxicityCarbo/Taxol Grade 3 and Above on Carbo/Taxol/Gemcitabine Grade 3 and Above on Carbo/Taxol/Doxil Grade 3 and Above on Carbo/Topotecan - Carbo/Taxol Grade 3 and Above on Carbo/Gemcitabine - Carbo/Taxol
Hide Arm/Group Description:
Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles
Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Gemcitabine 800 mg/m2/dIV on days 1 and 8 x 8 cycles
Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Doxil 30 mg/m2 IV every other cycle on day 1 x 8 cycles
Topotecan 1.25 mg/m2/dIV days 1-3 plus Carboplatin AUC 5 IV on day 3 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
Gemcitabine 1000 mg/m2/dIV on days 1 and 8 plus Carboplatin AUC 6 IV on day 8 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
Overall Number of Participants Analyzed 862 860 854 846 851
Measure Type: Count of Participants
Unit of Measure: Participants
Leukopenia
438
  50.8%
686
  79.8%
595
  69.7%
476
  56.3%
513
  60.3%
Neutropenia
749
  86.9%
798
  92.8%
782
  91.6%
779
  92.1%
761
  89.4%
Thrombocytopenia
193
  22.4%
520
  60.5%
320
  37.5%
303
  35.8%
486
  57.1%
Anemia
102
  11.8%
196
  22.8%
160
  18.7%
167
  19.7%
203
  23.9%
Other Hematologic
156
  18.1%
338
  39.3%
244
  28.6%
246
  29.1%
315
  37.0%
Allergy
38
   4.4%
20
   2.3%
28
   3.3%
21
   2.5%
26
   3.1%
Auditory
5
   0.6%
2
   0.2%
3
   0.4%
2
   0.2%
1
   0.1%
Cardiovascular
20
   2.3%
36
   4.2%
34
   4.0%
17
   2.0%
23
   2.7%
Coagulation
5
   0.6%
10
   1.2%
4
   0.5%
9
   1.1%
7
   0.8%
Constitutional
54
   6.3%
96
  11.2%
84
   9.8%
73
   8.6%
57
   6.7%
Dermatologic
13
   1.5%
6
   0.7%
11
   1.3%
6
   0.7%
8
   0.9%
Endocrine
0
   0.0%
4
   0.5%
2
   0.2%
1
   0.1%
1
   0.1%
Gastrointestinal
90
  10.4%
145
  16.9%
124
  14.5%
105
  12.4%
92
  10.8%
Genitourinary/Renal
9
   1.0%
8
   0.9%
13
   1.5%
6
   0.7%
9
   1.1%
Hemorrhage
8
   0.9%
29
   3.4%
20
   2.3%
8
   0.9%
30
   3.5%
Hepatic
13
   1.5%
32
   3.7%
11
   1.3%
13
   1.5%
25
   2.9%
Infection/Fever
76
   8.8%
138
  16.0%
134
  15.7%
84
   9.9%
82
   9.6%
Metabolic
61
   7.1%
55
   6.4%
55
   6.4%
37
   4.4%
45
   5.3%
Musculoskeletal
7
   0.8%
18
   2.1%
13
   1.5%
8
   0.9%
10
   1.2%
Neurologic
34
   3.9%
47
   5.5%
43
   5.0%
28
   3.3%
35
   4.1%
Peripheral Neurologic
45
   5.2%
59
   6.9%
45
   5.3%
35
   4.1%
24
   2.8%
Ocular/Visual
1
   0.1%
3
   0.3%
1
   0.1%
3
   0.4%
3
   0.4%
Pain
53
   6.1%
75
   8.7%
75
   8.8%
66
   7.8%
52
   6.1%
Pulmonary
19
   2.2%
37
   4.3%
39
   4.6%
21
   2.5%
37
   4.3%
Sexual
0
   0.0%
0
   0.0%
1
   0.1%
1
   0.1%
0
   0.0%
Second Primary
34
   3.9%
66
   7.7%
51
   6.0%
41
   4.8%
57
   6.7%
Time Frame From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred.
Adverse Event Reporting Description Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected &/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs & non-serious AEs. Other AEs are Grade 2 or worse.
 
Arm/Group Title Carbo/Taxol Carbo/Taxol/Gemcitabine Carbo/Taxol/Doxil Carbo/Topotecan - Carbo/Taxol Carbo/Gemcitabine - Carbo/Taxol
Hide Arm/Group Description Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Gemcitabine 800 mg/m2/dIV on days 1 and 8 x 8 cycles Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Doxil 30 mg/m2 IV every other cycle on day 1 x 8 cycles Topotecan 1.25 mg/m2/dIV days 1-3 plus Carboplatin AUC 5 IV on day 3 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles Gemcitabine 1000 mg/m2/dIV on days 1 and 8 plus Carboplatin AUC 6 IV on day 8 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
All-Cause Mortality
Carbo/Taxol Carbo/Taxol/Gemcitabine Carbo/Taxol/Doxil Carbo/Topotecan - Carbo/Taxol Carbo/Gemcitabine - Carbo/Taxol
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Carbo/Taxol Carbo/Taxol/Gemcitabine Carbo/Taxol/Doxil Carbo/Topotecan - Carbo/Taxol Carbo/Gemcitabine - Carbo/Taxol
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   86/777 (11.07%)   107/774 (13.82%)   115/767 (14.99%)   77/766 (10.05%)   100/767 (13.04%) 
Blood and lymphatic system disorders           
Hemoglobin * 1  2/777 (0.26%)  2/774 (0.26%)  1/767 (0.13%)  0/766 (0.00%)  3/767 (0.39%) 
Platelets * 1  1/777 (0.13%)  12/774 (1.55%)  2/767 (0.26%)  0/766 (0.00%)  8/767 (1.04%) 
Neutrophils/Granulocytes * 1  1/777 (0.13%)  3/774 (0.39%)  3/767 (0.39%)  3/766 (0.39%)  1/767 (0.13%) 
Leukocytes * 1  0/777 (0.00%)  0/774 (0.00%)  0/767 (0.00%)  1/766 (0.13%)  0/767 (0.00%) 
Cardiac disorders           
Hypertension * 1  1/777 (0.13%)  0/774 (0.00%)  0/767 (0.00%)  1/766 (0.13%)  1/767 (0.13%) 
Circulatory Or Cardiac-Other * 1  0/777 (0.00%)  0/774 (0.00%)  1/767 (0.13%)  0/766 (0.00%)  1/767 (0.13%) 
Cardiac Left Ventricular Function * 1  0/777 (0.00%)  1/774 (0.13%)  1/767 (0.13%)  0/766 (0.00%)  1/767 (0.13%) 
Cardiac Troponin I * 1  0/777 (0.00%)  0/774 (0.00%)  1/767 (0.13%)  0/766 (0.00%)  0/767 (0.00%) 
Hypotension * 1  1/777 (0.13%)  0/774 (0.00%)  0/767 (0.00%)  0/766 (0.00%)  0/767 (0.00%) 
Sinus Tachycardia * 1  0/777 (0.00%)  1/774 (0.13%)  2/767 (0.26%)  0/766 (0.00%)  0/767 (0.00%) 
Phlebitis * 1  0/777 (0.00%)  1/774 (0.13%)  0/767 (0.00%)  0/766 (0.00%)  1/767 (0.13%) 
Vasovagal Episode * 1  0/777 (0.00%)  1/774 (0.13%)  0/767 (0.00%)  0/766 (0.00%)  0/767 (0.00%) 
Supraventricular Arrhythmias * 1  1/777 (0.13%)  1/774 (0.13%)  1/767 (0.13%)  0/766 (0.00%)  1/767 (0.13%) 
Thrombosis/Embolism * 1  10/777 (1.29%)  9/774 (1.16%)  13/767 (1.69%)  13/766 (1.70%)  16/767 (2.09%) 
Nodal/Junctional Arrhythmia/Dysrhythmia * 1  0/777 (0.00%)  0/774 (0.00%)  1/767 (0.13%)  0/766 (0.00%)  0/767 (0.00%) 
Arrhythmia- Other * 1  0/777 (0.00%)  0/774 (0.00%)  1/767 (0.13%)  0/766 (0.00%)  2/767 (0.26%) 
Cardiac-Ischemia/Infarction * 1  1/777 (0.13%)  1/774 (0.13%)  2/767 (0.26%)  1/766 (0.13%)  0/767 (0.00%) 
Sinus Bradycardia * 1  0/777 (0.00%)  1/774 (0.13%)  0/767 (0.00%)  0/766 (0.00%)  0/767 (0.00%) 
Edema * 1  0/777 (0.00%)  1/774 (0.13%)  0/767 (0.00%)  1/766 (0.13%)  1/767 (0.13%) 
Ear and labyrinth disorders           
Inner Ear/Hearing * 1  0/777 (0.00%)  0/774 (0.00%)  0/767 (0.00%)  0/766 (0.00%)  1/767 (0.13%) 
Hearing-Other * 1  0/777 (0.00%)  1/774 (0.13%)  0/767 (0.00%)  0/766 (0.00%)  0/767 (0.00%) 
Eye disorders           
Glaucoma * 1  0/777 (0.00%)  1/774 (0.13%)  0/767 (0.00%)  0/766 (0.00%)  0/767 (0.00%) 
Gastrointestinal disorders           
Stomatitis/Pharyngitis * 1  0/777 (0.00%)  0/774 (0.00%)  1/767 (0.13%)  0/766 (0.00%)  1/767 (0.13%) 
Pancreatitis * 1  0/777 (0.00%)  0/774 (0.00%)  0/767 (0.00%)  1/766 (0.13%)  0/767 (0.00%) 
Gi-Other * 1  1/777 (0.13%)  1/774 (0.13%)  0/767 (0.00%)  1/766 (0.13%)  0/767 (0.00%) 
Ileus * 1  5/777 (0.64%)  4/774 (0.52%)  2/767 (0.26%)  4/766 (0.52%)  5/767 (0.65%) 
Gastritis * 1  0/777 (0.00%)  0/774 (0.00%)  0/767 (0.00%)  2/766 (0.26%)  0/767 (0.00%) 
Anorexia * 1  0/777 (0.00%)  0/774 (0.00%)  0/767 (0.00%)  0/766 (0.00%)  1/767 (0.13%) 
Dyspepsia/Heartburn * 1  0/777 (0.00%)  0/774 (0.00%)  1/767 (0.13%)  1/766 (0.13%)  0/767 (0.00%) 
Gastric Ulcer * 1  1/777 (0.13%)  0/774 (0.00%)  1/767 (0.13%)  0/766 (0.00%)  0/767 (0.00%) 
Colitis * 1  0/777 (0.00%)  1/774 (0.13%)  1/767 (0.13%)  0/766 (0.00%)  0/767 (0.00%) 
Ascites (Non-Malignant) * 1  0/777 (0.00%)  1/774 (0.13%)  1/767 (0.13%)  1/766 (0.13%)  1/767 (0.13%) 
Fistula-Rectal/Anal * 1  0/777 (0.00%)  0/774 (0.00%)  0/767 (0.00%)  1/766 (0.13%)  0/767 (0.00%) 
Dehydration * 1  2/777 (0.26%)  3/774 (0.39%)  2/767 (0.26%)  2/766 (0.26%)  1/767 (0.13%) 
Constipation * 1  6/777 (0.77%)  7/774 (0.90%)  3/767 (0.39%)  5/766 (0.65%)  3/767 (0.39%) 
Diarrhea (Without Colostomy) * 1  1/777 (0.13%)  4/774 (0.52%)  3/767 (0.39%)  1/766 (0.13%)  2/767 (0.26%) 
Vomiting * 1  7/777 (0.90%)  8/774 (1.03%)  11/767 (1.43%)  7/766 (0.91%)  1/767 (0.13%) 
Nausea * 1  0/777 (0.00%)  0/774 (0.00%)  2/767 (0.26%)  1/766 (0.13%)  1/767 (0.13%) 
General disorders           
Constitutional Symptoms-Other * 1  1/777 (0.13%)  0/774 (0.00%)  0/767 (0.00%)  0/766 (0.00%)  0/767 (0.00%) 
Fever In The Absence Of Neutropenia * 1  0/777 (0.00%)  0/774 (0.00%)  0/767 (0.00%)  1/766 (0.13%)  0/767 (0.00%) 
Fatigue * 1  0/777 (0.00%)  3/774 (0.39%)  1/767 (0.13%)  1/766 (0.13%)  0/767 (0.00%) 
Chest Pain Non-Cardiac Or Non-Pleuritic * 1  0/777 (0.00%)  0/774 (0.00%)  1/767 (0.13%)  1/766 (0.13%)  0/767 (0.00%) 
Headache * 1  0/777 (0.00%)  0/774 (0.00%)  1/767 (0.13%)  0/766 (0.00%)  0/767 (0.00%) 
Abdominal Pain Or Cramping * 1  4/777 (0.51%)  3/774 (0.39%)  4/767 (0.52%)  1/766 (0.13%)  1/767 (0.13%) 
Bone Pain * 1  1/777 (0.13%)  0/774 (0.00%)  0/767 (0.00%)  0/766 (0.00%)  0/767 (0.00%) 
Arthralgia * 1  0/777 (0.00%)  0/774 (0.00%)  1/767 (0.13%)  0/766 (0.00%)  0/767 (0.00%) 
Myalgia * 1  1/777 (0.13%)  0/774 (0.00%)  0/767 (0.00%)  0/766 (0.00%)  0/767 (0.00%) 
Pain-Other * 1  0/777 (0.00%)  1/774 (0.13%)  1/767 (0.13%)  0/766 (0.00%)  1/767 (0.13%) 
Hepatobiliary disorders           
Hepatic-Other * 1  0/777 (0.00%)  0/774 (0.00%)  0/767 (0.00%)  1/766 (0.13%)  1/767 (0.13%) 
Sgpt * 1  0/777 (0.00%)  0/774 (0.00%)  0/767 (0.00%)  0/766 (0.00%)  1/767 (0.13%) 
Sgot * 1  0/777 (0.00%)  2/774 (0.26%)  0/767 (0.00%)  1/766 (0.13%)  1/767 (0.13%) 
Bilirubin * 1  0/777 (0.00%)  0/774 (0.00%)  1/767 (0.13%)  0/766 (0.00%)  0/767 (0.00%) 
Immune system disorders           
Allergy-Other * 1  4/777 (0.51%)  0/774 (0.00%)  2/767 (0.26%)  1/766 (0.13%)  0/767 (0.00%) 
Allergic Reaction/Hypersensitivity * 1  9/777 (1.16%)  6/774 (0.78%)  6/767 (0.78%)  3/766 (0.39%)  6/767 (0.78%) 
Infections and infestations           
Infection, Other * 1  1/777 (0.13%)  1/774 (0.13%)  0/767 (0.00%)  0/766 (0.00%)  2/767 (0.26%) 
Catheter-Related Infection * 1  0/777 (0.00%)  1/774 (0.13%)  1/767 (0.13%)  0/766 (0.00%)  0/767 (0.00%) 
Infection With Unknown Anc * 1  0/777 (0.00%)  1/774 (0.13%)  1/767 (0.13%)  1/766 (0.13%)  2/767 (0.26%) 
Infection Documented W Grd 3/4 Neutropn. * 1  5/777 (0.64%)  9/774 (1.16%)  15/767 (1.96%)  7/766 (0.91%)  4/767 (0.52%) 
Infection Without Neutropenia * 1  7/777 (0.90%)  8/774 (1.03%)  5/767 (0.65%)  6/766 (0.78%)  6/767 (0.78%) 
Febrile Neutropenia-Fuo Infect Not Docum * 1  8/777 (1.03%)  12/774 (1.55%)  15/767 (1.96%)  10/766 (1.31%)  7/767 (0.91%) 
Metabolism and nutrition disorders           
Metabolic-Other * 1  0/777 (0.00%)  1/774 (0.13%)  0/767 (0.00%)  1/766 (0.13%)  0/767 (0.00%) 
Hyponatremia * 1  0/777 (0.00%)  1/774 (0.13%)  0/767 (0.00%)  1/766 (0.13%)  1/767 (0.13%) 
Hyperkalemia * 1  0/777 (0.00%)  0/774 (0.00%)  0/767 (0.00%)  0/766 (0.00%)  1/767 (0.13%) 
Hyperglycemia * 1  0/777 (0.00%)  0/774 (0.00%)  0/767 (0.00%)  1/766 (0.13%)  0/767 (0.00%) 
Hypokalemia * 1  0/777 (0.00%)  0/774 (0.00%)  0/767 (0.00%)  0/766 (0.00%)  2/767 (0.26%) 
Hypomagnesmia * 1  0/777 (0.00%)  1/774 (0.13%)  0/767 (0.00%)  0/766 (0.00%)  0/767 (0.00%) 
Musculoskeletal and connective tissue disorders           
Joint, Muscle, Or Bone-Other * 1  0/777 (0.00%)  0/774 (0.00%)  1/767 (0.13%)  0/766 (0.00%)  0/767 (0.00%) 
Nervous system disorders           
Tremor * 1  0/777 (0.00%)  2/774 (0.26%)  0/767 (0.00%)  0/766 (0.00%)  0/767 (0.00%) 
Speech Impairment- Dysphasia/Aphasia * 1  0/777 (0.00%)  0/774 (0.00%)  1/767 (0.13%)  0/766 (0.00%)  0/767 (0.00%) 
Seizure(S) * 1  1/777 (0.13%)  0/774 (0.00%)  0/767 (0.00%)  0/766 (0.00%)  2/767 (0.26%) 
Hallucinations * 1  0/777 (0.00%)  0/774 (0.00%)  0/767 (0.00%)  0/766 (0.00%)  1/767 (0.13%) 
Cns Cerebrovascular Ischemia * 1  0/777 (0.00%)  0/774 (0.00%)  4/767 (0.52%)  0/766 (0.00%)  2/767 (0.26%) 
Confusion * 1  0/777 (0.00%)  0/774 (0.00%)  1/767 (0.13%)  1/766 (0.13%)  1/767 (0.13%) 
Syncope * 1  6/777 (0.77%)  2/774 (0.26%)  5/767 (0.65%)  0/766 (0.00%)  3/767 (0.39%) 
Mood Alteration-Anxiety Agitation * 1  0/777 (0.00%)  1/774 (0.13%)  0/767 (0.00%)  1/766 (0.13%)  0/767 (0.00%) 
Dizziness/Lightheadedness * 1  0/777 (0.00%)  0/774 (0.00%)  0/767 (0.00%)  1/766 (0.13%)  1/767 (0.13%) 
Neuropathy-Sensory * 1  1/777 (0.13%)  0/774 (0.00%)  1/767 (0.13%)  0/766 (0.00%)  0/767 (0.00%) 
Neuropathy Motor * 1  1/777 (0.13%)  1/774 (0.13%)  1/767 (0.13%)  0/766 (0.00%)  1/767 (0.13%) 
Renal and urinary disorders           
Operative Injury To Bladder/Ureter * 1  0/777 (0.00%)  0/774 (0.00%)  0/767 (0.00%)  0/766 (0.00%)  1/767 (0.13%) 
Fistula Or Gu Fistula * 1  0/777 (0.00%)  0/774 (0.00%)  2/767 (0.26%)  0/766 (0.00%)  0/767 (0.00%) 
Renal Failure * 1  0/777 (0.00%)  0/774 (0.00%)  2/767 (0.26%)  1/766 (0.13%)  1/767 (0.13%) 
Creatinine * 1  1/777 (0.13%)  0/774 (0.00%)  0/767 (0.00%)  0/766 (0.00%)  1/767 (0.13%) 
Renal/Gu-Other * 1  0/777 (0.00%)  0/774 (0.00%)  0/767 (0.00%)  0/766 (0.00%)  1/767 (0.13%) 
Respiratory, thoracic and mediastinal disorders           
Pleural Effusion (Non-Malignant) * 1  1/777 (0.13%)  2/774 (0.26%)  2/767 (0.26%)  1/766 (0.13%)  3/767 (0.39%) 
Dyspnea * 1  1/777 (0.13%)  3/774 (0.39%)  4/767 (0.52%)  3/766 (0.39%)  0/767 (0.00%) 
Pneumothorax * 1  0/777 (0.00%)  0/774 (0.00%)  0/767 (0.00%)  0/766 (0.00%)  1/767 (0.13%) 
Hypoxia * 1  0/777 (0.00%)  2/774 (0.26%)  0/767 (0.00%)  0/766 (0.00%)  0/767 (0.00%) 
Adult Respiratory Distress Syndrome * 1  0/777 (0.00%)  1/774 (0.13%)  1/767 (0.13%)  0/766 (0.00%)  1/767 (0.13%) 
Skin and subcutaneous tissue disorders           
Pruritus * 1  1/777 (0.13%)  0/774 (0.00%)  0/767 (0.00%)  0/766 (0.00%)  0/767 (0.00%) 
Urticaria * 1  0/777 (0.00%)  0/774 (0.00%)  1/767 (0.13%)  1/766 (0.13%)  1/767 (0.13%) 
Wound-Infectious * 1  1/777 (0.13%)  1/774 (0.13%)  0/767 (0.00%)  1/766 (0.13%)  2/767 (0.26%) 
Rash/Desquamation * 1  0/777 (0.00%)  1/774 (0.13%)  0/767 (0.00%)  0/766 (0.00%)  2/767 (0.26%) 
Skin-Other * 1  0/777 (0.00%)  0/774 (0.00%)  0/767 (0.00%)  0/766 (0.00%)  1/767 (0.13%) 
Wound-Non-Infectious * 1  0/777 (0.00%)  0/774 (0.00%)  1/767 (0.13%)  0/766 (0.00%)  0/767 (0.00%) 
Erythema Multiforme * 1  0/777 (0.00%)  1/774 (0.13%)  0/767 (0.00%)  0/766 (0.00%)  0/767 (0.00%) 
Vascular disorders           
Hemorrhage-Other * 1  0/777 (0.00%)  0/774 (0.00%)  0/767 (0.00%)  0/766 (0.00%)  1/767 (0.13%) 
Rectal Bleeding/Hematochezia * 1  0/777 (0.00%)  1/774 (0.13%)  0/767 (0.00%)  0/766 (0.00%)  1/767 (0.13%) 
Hemorrhage/Bleeding Associated With Surgery * 1  0/777 (0.00%)  0/774 (0.00%)  0/767 (0.00%)  0/766 (0.00%)  1/767 (0.13%) 
Epistaxis * 1  0/777 (0.00%)  0/774 (0.00%)  0/767 (0.00%)  1/766 (0.13%)  1/767 (0.13%) 
Hemorrhage/Bleeding With Grade 3 Or 4 Th * 1  0/777 (0.00%)  0/774 (0.00%)  1/767 (0.13%)  0/766 (0.00%)  0/767 (0.00%) 
Hematuria (In The Absence Of Vaginal Bleeding * 1  1/777 (0.13%)  0/774 (0.00%)  0/767 (0.00%)  0/766 (0.00%)  0/767 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Carbo/Taxol Carbo/Taxol/Gemcitabine Carbo/Taxol/Doxil Carbo/Topotecan - Carbo/Taxol Carbo/Gemcitabine - Carbo/Taxol
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   857/862 (99.42%)   856/860 (99.53%)   852/854 (99.77%)   843/846 (99.65%)   849/851 (99.76%) 
Blood and lymphatic system disorders           
Leukopenia * 1  746/862 (86.54%)  826/860 (96.05%)  806/854 (94.38%)  782/846 (92.43%)  800/851 (94.01%) 
Neutropenia * 1  821/862 (95.24%)  838/860 (97.44%)  818/854 (95.78%)  830/846 (98.11%)  825/851 (96.94%) 
Thrombocytopenia * 1  319/862 (37.01%)  675/860 (78.49%)  438/854 (51.29%)  460/846 (54.37%)  645/851 (75.79%) 
Anemia * 1  508/862 (58.93%)  700/860 (81.40%)  603/854 (70.61%)  647/846 (76.48%)  685/851 (80.49%) 
Other Hemotologic * 1  164/862 (19.03%)  351/860 (40.81%)  261/854 (30.56%)  260/846 (30.73%)  327/851 (38.43%) 
Hemorrhage * 1  14/862 (1.62%)  41/860 (4.77%)  33/854 (3.86%)  18/846 (2.13%)  50/851 (5.88%) 
Cardiac disorders           
Cardiovascular * 1  43/862 (4.99%)  72/860 (8.37%)  62/854 (7.26%)  36/846 (4.26%)  61/851 (7.17%) 
Ear and labyrinth disorders           
Auditory * 1  22/862 (2.55%)  20/860 (2.33%)  23/854 (2.69%)  17/846 (2.01%)  15/851 (1.76%) 
Endocrine disorders           
Endocrine * 1  36/862 (4.18%)  38/860 (4.42%)  41/854 (4.80%)  40/846 (4.73%)  27/851 (3.17%) 
Eye disorders           
Ocular/Visual * 1  42/862 (4.87%)  54/860 (6.28%)  64/854 (7.49%)  28/846 (3.31%)  38/851 (4.47%) 
Gastrointestinal disorders           
Gastrointestinal * 1  421/862 (48.84%)  469/860 (54.53%)  496/854 (58.08%)  403/846 (47.64%)  399/851 (46.89%) 
General disorders           
Constitutional * 1  365/862 (42.34%)  434/860 (50.47%)  403/854 (47.19%)  367/846 (43.38%)  363/851 (42.66%) 
Pain * 1  317/862 (36.77%)  301/860 (35.00%)  294/854 (34.43%)  295/846 (34.87%)  289/851 (33.96%) 
Hepatobiliary disorders           
Hepatic * 1  43/862 (4.99%)  96/860 (11.16%)  42/854 (4.92%)  39/846 (4.61%)  79/851 (9.28%) 
Immune system disorders           
Allergy * 1  65/862 (7.54%)  42/860 (4.88%)  54/854 (6.32%)  39/846 (4.61%)  47/851 (5.52%) 
Infections and infestations           
Infection/Fever * 1  135/862 (15.66%)  196/860 (22.79%)  199/854 (23.30%)  143/846 (16.90%)  147/851 (17.27%) 
Metabolism and nutrition disorders           
Metabolic * 1  118/862 (13.69%)  98/860 (11.40%)  107/854 (12.53%)  79/846 (9.34%)  97/851 (11.40%) 
Musculoskeletal and connective tissue disorders           
Musculoskeletal * 1  55/862 (6.38%)  62/860 (7.21%)  52/854 (6.09%)  44/846 (5.20%)  45/851 (5.29%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
2nd Primary * 1  70/862 (8.12%)  94/860 (10.93%)  85/854 (9.95%)  74/846 (8.75%)  85/851 (9.99%) 
Nervous system disorders           
Neurologic * 1  117/862 (13.57%)  135/860 (15.70%)  110/854 (12.88%)  90/846 (10.64%)  119/851 (13.98%) 
Peripheral neurologic * 1  207/862 (24.01%)  232/860 (26.98%)  207/854 (24.24%)  134/846 (15.84%)  144/851 (16.92%) 
Renal and urinary disorders           
Genitourinary/Renal * 1  46/862 (5.34%)  53/860 (6.16%)  56/854 (6.56%)  36/846 (4.26%)  42/851 (4.94%) 
Reproductive system and breast disorders           
Sexual * 1  4/862 (0.46%)  9/860 (1.05%)  11/854 (1.29%)  6/846 (0.71%)  5/851 (0.59%) 
Respiratory, thoracic and mediastinal disorders           
Pulmonary * 1  104/861 (12.08%)  129/860 (15.00%)  118/854 (13.82%)  106/846 (12.53%)  145/851 (17.04%) 
Skin and subcutaneous tissue disorders           
Dermatologic * 1  63/862 (7.31%)  61/860 (7.09%)  109/854 (12.76%)  47/846 (5.56%)  64/851 (7.52%) 
Vascular disorders           
Coagulation * 1  10/862 (1.16%)  12/860 (1.40%)  6/854 (0.70%)  14/846 (1.65%)  10/851 (1.18%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Name/Title: Linda Gedeon, BS, CCRP
Organization: Gynecologic Oncology Group Statistical and Data Center
Phone: 716-845-1169
Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00011986     History of Changes
Other Study ID Numbers: GOG-0182
NCI-2012-02376 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
SWOG-G0182
CDR0000068467
ISRCTN41636183
MRC-ICON5
ECOG-G0182
GOG-0182 ( Other Identifier: Gynecologic Oncology Group )
GOG-0182 ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: March 3, 2001
First Posted: January 27, 2003
Results First Submitted: February 18, 2014
Results First Posted: April 19, 2016
Last Update Posted: April 16, 2019