Primary Peritoneal Carcinoma, Stage III Ovarian Cancer, Stage IV Ovarian Cancer
Conditions
Brief summary
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is most effective in treating ovarian epithelial cancer and peritoneal cancer. Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens in treating patients who have stage III or stage IV ovarian cancer or primary peritoneal cancer.
Detailed description
OBJECTIVES: Compare the efficacy of paclitaxel and carboplatin with or without gemcitabine, doxorubicin HCl liposome, or topotecan, in terms of overall and progression-free survival, in patients with stage III or IV ovarian epithelial or serous primary peritoneal carcinoma. Determine the response rate in patients with measurable disease treated with these regimens. Compare the toxic effects of these regimens in these patients. Compare the complications in patients treated with these regimens. Determine the dose-intensity and cumulative dose delivery for these regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified into 1 of 3 strata according to extent of residual disease and plans for interval cytoreductive surgery: Stratum A: Optimal (microscopic or macroscopic) residual disease without plans for surgery Stratum B: Suboptimal residual disease without plans for surgery Stratum C: Suboptimal residual disease with plans for surgeryPatients are randomized to 1 of 5 treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment continues every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive chemotherapy as in arm I and gemcitabine IV over 30 minutes on days 1 and 8. Treatment continues as in arm I. Arm III: Patients receive chemotherapy as in arm I during courses 1-8 and doxorubicin HCl liposome IV over 1 hour on day 1 during courses 1, 3, 5, and 7. Treatment continues as in arm I. Arm IV: Patients receive topotecan IV over 30 minutes on days 1-3 and carboplatin IV over 30 minutes on day 3. Treatment continues every 3 weeks for 4 courses. Patients then receive 4 courses of arm I chemotherapy. Arm V: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 8. Treatment continues every 3 weeks for 4 courses. Patients then receive 4 courses of arm I chemotherapy. Patients with initial unresectable or suboptimal residual disease (more than 1 cm) may undergo interval cytoreductive surgery between courses 4 and 5 of chemotherapy. Patients are followed every 3 months for 2 years and then every 6 months. PROJECTED ACCRUAL: Approximately 4,000-5,000 patients (800-1,000 per treatment arm) will be accrued for this study within 3.5-5 years.
Interventions
DRUGPaclitaxel
Given IV
DRUGCarboplatin
Given IV
DRUGGemcitabine Hydrochloride
Given IV
DRUGPegylated Liposomal Doxorubicin Hydrochloride
DRUGTopotecan Hydrochloride
Given IV
PROCEDURETherapeutic Conventional Surgery
Undergo surgery
Sponsors
SWOG Cancer Research Network
Medical Research Council
National Cancer Institute (NCI)
Gynecologic Oncology Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed stage III or IV ovarian epithelial or serous primaryperitoneal carcinoma * The following are ineligible: * Germ cell tumors * Sex cord-stromal tumors * Carcinosarcomas * Mixed Mullerian tumors or carcinosarcomas * Metastatic carcinomas from other sites to theovary * Low malignant potential tumors, including micropapillary serouscarcinomas * Mucinous primary peritoneal carcinoma * Prior ovarian low malignant potential tumor (borderline carcinoma) that was surgically resected with subsequent development of invasive adenocarcinoma allowed if no prior chemotherapy * Optimal (no greater than 1 cm) or suboptimal residual disease after initial surgery * Prior breast cancer allowed provided the following are true: * Disease-free for more than 5 years * No prior cytotoxic chemotherapy for breast cancer * Prior or concurrent primary endometrial cancer allowed if the following conditions are met: * Stage no greater than IB * Less than 3 mm invasion without vascular or lymphatic invasion * No poorly differentiated subtypes, including papillary serous, clear cell, or other FIGO grade 3 lesions * Performance status - GOG 0-2 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST no greater than 2.5 times ULN * Alkaline phosphatase no greater than 2.5 times ULN * No acute hepatitis * Creatinine no greater than 1.5 times ULN * No unstable angina * No myocardial infarction within the past 6 months * No evidence of abnormal cardiac conduction (e.g., bundle branch block, heart block) unless stable for the past 6 months * Not pregnant or nursing * Fertile patients must use effective contraception * No greater than grade 1 sensory or motor neuropathy * No active infection that requires antibiotics * No other invasive malignancy within the past 5 years except nonmelanoma skin cancer * No severe or ongoing gastrointestinal bleeding that requires blood product support * See Disease Characteristics * Prior chemotherapy for cancer involving the abdominal cavity or pelvis allowed provided the following are true: * More than 3 years since prior therapy * No evidence of recurrent disease * No prior radiotherapy to any portion of the abdominal cavity or pelvis * Prior radiotherapy for localized breast, head and neck, or skin cancer allowed provided the following are true: * More than 3 years since prior therapy * No evidence of recurrent disease * See Disease Characteristics * No more than 12 weeks since prior surgical resection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Up to 9 years | Proportion of participants whose overall survival exceeded 5 years. |
| Progression-free Survival | From the date of enrollment to first progression or death or last contact, if alive and progression free. | Median duration in months of progression free survival. |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Up to 9 years |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Carbo/Taxol Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles | 864 |
| Carbo/Taxol/Gemcitabine 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 | 864 |
| Carbo/Taxol/Doxil 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 | 862 |
| Carbo/Topotecan - Carbo/Taxol 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 | 861 |
| Carbo/Gemcitabine - Carbo/Taxol 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 | 861 |
| Total | 4,312 |
Baseline characteristics
| Characteristic | Carbo/Taxol/Gemcitabine | Carbo/Taxol | Carbo/Taxol/Doxil | Carbo/Topotecan - Carbo/Taxol | Carbo/Gemcitabine - Carbo/Taxol | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 58.8 years STANDARD_DEVIATION 10.8 | 57.8 years STANDARD_DEVIATION 11.1 | 59.0 years STANDARD_DEVIATION 11.1 | 58.2 years STANDARD_DEVIATION 11 | 58.9 years STANDARD_DEVIATION 10.7 | 58.6 years STANDARD_DEVIATION 10.9 |
| International Federation of Gynecology and Obstetrics (FIGO) Stage Stage III:see description for details | 749 participants | 724 participants | 743 participants | 744 participants | 721 participants | 3681 participants |
| International Federation of Gynecology and Obstetrics (FIGO) Stage Stage IV:see description for details | 115 participants | 140 participants | 119 participants | 117 participants | 140 participants | 631 participants |
| Primary Site of Disease Ovary | 752 participants | 748 participants | 737 participants | 752 participants | 751 participants | 3740 participants |
| Primary Site of Disease Peritoneum | 112 participants | 116 participants | 125 participants | 109 participants | 110 participants | 572 participants |
| Sex: Female, Male Female | 864 Participants | 864 Participants | 862 Participants | 861 Participants | 861 Participants | 4312 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Size of Residual Disease ≤ 1 cm gross disease | 384 participants | 404 participants | 405 participants | 358 participants | 398 participants | 1949 participants |
| Size of Residual Disease > 1 cm gross disease | 262 participants | 263 participants | 251 participants | 283 participants | 260 participants | 1319 participants |
| Size of Residual Disease Microscopic only | 218 participants | 197 participants | 206 participants | 220 participants | 203 participants | 1044 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 857 / 862 | 856 / 860 | 852 / 854 | 843 / 846 | 849 / 851 |
| serious Total, serious adverse events | 86 / 777 | 107 / 774 | 115 / 767 | 77 / 766 | 100 / 767 |
Outcome results
Primary
Overall Survival
Proportion of participants whose overall survival exceeded 5 years.
Time frame: Up to 9 years
Population: All enrolled participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Carbo/Taxol | Overall Survival | 0.35 Proportion of participants |
| Carbo/Taxol/Gemcitabine | Overall Survival | 0.34 Proportion of participants |
| Carbo/Taxol/Doxil | Overall Survival | 0.39 Proportion of participants |
| Carbo/Topotecan - Carbo/Taxol | Overall Survival | 0.34 Proportion of participants |
| Carbo/Gemcitabine - Carbo/Taxol | Overall Survival | 0.30 Proportion of participants |
Primary
Progression-free Survival
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Carbo/Taxol | Progression-free Survival | 16.0 months |
| Carbo/Taxol/Gemcitabine | Progression-free Survival | 16.3 months |
| Carbo/Taxol/Doxil | Progression-free Survival | 16.4 months |
| Carbo/Topotecan - Carbo/Taxol | Progression-free Survival | 15.4 months |
| Carbo/Gemcitabine - Carbo/Taxol | Progression-free Survival | 15.4 months |
Secondary
Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0
Time frame: Up to 9 years
Population: Eligible and treated participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Sexual | 0 Participants |
| Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Allergy | 38 Participants |
| Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Metabolic | 61 Participants |
| Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Leukopenia | 438 Participants |
| Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Hepatic | 13 Participants |
| Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Constitutional | 54 Participants |
| Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Auditory | 5 Participants |
| Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Genitourinary/Renal | 9 Participants |
| Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Coagulation | 5 Participants |
| Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Neutropenia | 749 Participants |
| Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Infection/Fever | 76 Participants |
| Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Cardiovascular | 20 Participants |
| Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Gastrointestinal | 90 Participants |
| Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Pulmonary | 19 Participants |
| Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Musculoskeletal | 7 Participants |
| Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Hemorrhage | 8 Participants |
| Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Thrombocytopenia | 193 Participants |
| Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Endocrine | 0 Participants |
| Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Ocular/Visual | 1 Participants |
| Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Neurologic | 34 Participants |
| Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Pain | 53 Participants |
| Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Anemia | 102 Participants |
| Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Other Hematologic | 156 Participants |
| Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Peripheral Neurologic | 45 Participants |
| Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Second Primary | 34 Participants |
| Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Dermatologic | 13 Participants |
| Carbo/Taxol/Gemcitabine | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Genitourinary/Renal | 8 Participants |
| Carbo/Taxol/Gemcitabine | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Peripheral Neurologic | 59 Participants |
| Carbo/Taxol/Gemcitabine | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Infection/Fever | 138 Participants |
| Carbo/Taxol/Gemcitabine | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Metabolic | 55 Participants |
| Carbo/Taxol/Gemcitabine | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Anemia | 196 Participants |
| Carbo/Taxol/Gemcitabine | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Musculoskeletal | 18 Participants |
| Carbo/Taxol/Gemcitabine | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Neurologic | 47 Participants |
| Carbo/Taxol/Gemcitabine | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Sexual | 0 Participants |
| Carbo/Taxol/Gemcitabine | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Other Hematologic | 338 Participants |
| Carbo/Taxol/Gemcitabine | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Allergy | 20 Participants |
| Carbo/Taxol/Gemcitabine | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Second Primary | 66 Participants |
| Carbo/Taxol/Gemcitabine | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Auditory | 2 Participants |
| Carbo/Taxol/Gemcitabine | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Pulmonary | 37 Participants |
| Carbo/Taxol/Gemcitabine | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Cardiovascular | 36 Participants |
| Carbo/Taxol/Gemcitabine | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Neutropenia | 798 Participants |
| Carbo/Taxol/Gemcitabine | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Coagulation | 10 Participants |
| Carbo/Taxol/Gemcitabine | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Constitutional | 96 Participants |
| Carbo/Taxol/Gemcitabine | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Pain | 75 Participants |
| Carbo/Taxol/Gemcitabine | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Dermatologic | 6 Participants |
| Carbo/Taxol/Gemcitabine | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Endocrine | 4 Participants |
| Carbo/Taxol/Gemcitabine | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Gastrointestinal | 145 Participants |
| Carbo/Taxol/Gemcitabine | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Thrombocytopenia | 520 Participants |
| Carbo/Taxol/Gemcitabine | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Ocular/Visual | 3 Participants |
| Carbo/Taxol/Gemcitabine | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Hepatic | 32 Participants |
| Carbo/Taxol/Gemcitabine | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Hemorrhage | 29 Participants |
| Carbo/Taxol/Gemcitabine | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Leukopenia | 686 Participants |
| Carbo/Taxol/Doxil | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Second Primary | 51 Participants |
| Carbo/Taxol/Doxil | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Thrombocytopenia | 320 Participants |
| Carbo/Taxol/Doxil | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Dermatologic | 11 Participants |
| Carbo/Taxol/Doxil | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Other Hematologic | 244 Participants |
| Carbo/Taxol/Doxil | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Leukopenia | 595 Participants |
| Carbo/Taxol/Doxil | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Anemia | 160 Participants |
| Carbo/Taxol/Doxil | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Infection/Fever | 134 Participants |
| Carbo/Taxol/Doxil | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Endocrine | 2 Participants |
| Carbo/Taxol/Doxil | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Musculoskeletal | 13 Participants |
| Carbo/Taxol/Doxil | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Ocular/Visual | 1 Participants |
| Carbo/Taxol/Doxil | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Neurologic | 43 Participants |
| Carbo/Taxol/Doxil | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Sexual | 1 Participants |
| Carbo/Taxol/Doxil | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Gastrointestinal | 124 Participants |
| Carbo/Taxol/Doxil | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Peripheral Neurologic | 45 Participants |
| Carbo/Taxol/Doxil | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Hemorrhage | 20 Participants |
| Carbo/Taxol/Doxil | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Cardiovascular | 34 Participants |
| Carbo/Taxol/Doxil | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Auditory | 3 Participants |
| Carbo/Taxol/Doxil | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Metabolic | 55 Participants |
| Carbo/Taxol/Doxil | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Coagulation | 4 Participants |
| Carbo/Taxol/Doxil | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Neutropenia | 782 Participants |
| Carbo/Taxol/Doxil | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Pain | 75 Participants |
| Carbo/Taxol/Doxil | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Pulmonary | 39 Participants |
| Carbo/Taxol/Doxil | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Hepatic | 11 Participants |
| Carbo/Taxol/Doxil | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Constitutional | 84 Participants |
| Carbo/Taxol/Doxil | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Allergy | 28 Participants |
| Carbo/Taxol/Doxil | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Genitourinary/Renal | 13 Participants |
| Carbo/Topotecan - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Gastrointestinal | 105 Participants |
| Carbo/Topotecan - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Leukopenia | 476 Participants |
| Carbo/Topotecan - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Neutropenia | 779 Participants |
| Carbo/Topotecan - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Thrombocytopenia | 303 Participants |
| Carbo/Topotecan - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Anemia | 167 Participants |
| Carbo/Topotecan - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Other Hematologic | 246 Participants |
| Carbo/Topotecan - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Allergy | 21 Participants |
| Carbo/Topotecan - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Auditory | 2 Participants |
| Carbo/Topotecan - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Cardiovascular | 17 Participants |
| Carbo/Topotecan - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Coagulation | 9 Participants |
| Carbo/Topotecan - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Constitutional | 73 Participants |
| Carbo/Topotecan - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Dermatologic | 6 Participants |
| Carbo/Topotecan - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Endocrine | 1 Participants |
| Carbo/Topotecan - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Sexual | 1 Participants |
| Carbo/Topotecan - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Genitourinary/Renal | 6 Participants |
| Carbo/Topotecan - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Hemorrhage | 8 Participants |
| Carbo/Topotecan - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Hepatic | 13 Participants |
| Carbo/Topotecan - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Infection/Fever | 84 Participants |
| Carbo/Topotecan - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Metabolic | 37 Participants |
| Carbo/Topotecan - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Musculoskeletal | 8 Participants |
| Carbo/Topotecan - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Neurologic | 28 Participants |
| Carbo/Topotecan - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Peripheral Neurologic | 35 Participants |
| Carbo/Topotecan - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Ocular/Visual | 3 Participants |
| Carbo/Topotecan - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Pain | 66 Participants |
| Carbo/Topotecan - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Pulmonary | 21 Participants |
| Carbo/Topotecan - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Second Primary | 41 Participants |
| Carbo/Gemcitabine - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Hemorrhage | 30 Participants |
| Carbo/Gemcitabine - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Neutropenia | 761 Participants |
| Carbo/Gemcitabine - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Peripheral Neurologic | 24 Participants |
| Carbo/Gemcitabine - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Genitourinary/Renal | 9 Participants |
| Carbo/Gemcitabine - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Gastrointestinal | 92 Participants |
| Carbo/Gemcitabine - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Endocrine | 1 Participants |
| Carbo/Gemcitabine - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Leukopenia | 513 Participants |
| Carbo/Gemcitabine - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Ocular/Visual | 3 Participants |
| Carbo/Gemcitabine - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Dermatologic | 8 Participants |
| Carbo/Gemcitabine - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Constitutional | 57 Participants |
| Carbo/Gemcitabine - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Coagulation | 7 Participants |
| Carbo/Gemcitabine - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Sexual | 0 Participants |
| Carbo/Gemcitabine - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Pain | 52 Participants |
| Carbo/Gemcitabine - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Cardiovascular | 23 Participants |
| Carbo/Gemcitabine - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Auditory | 1 Participants |
| Carbo/Gemcitabine - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Allergy | 26 Participants |
| Carbo/Gemcitabine - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Second Primary | 57 Participants |
| Carbo/Gemcitabine - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Pulmonary | 37 Participants |
| Carbo/Gemcitabine - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Other Hematologic | 315 Participants |
| Carbo/Gemcitabine - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Anemia | 203 Participants |
| Carbo/Gemcitabine - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Musculoskeletal | 10 Participants |
| Carbo/Gemcitabine - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Metabolic | 45 Participants |
| Carbo/Gemcitabine - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Thrombocytopenia | 486 Participants |
| Carbo/Gemcitabine - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Neurologic | 35 Participants |
| Carbo/Gemcitabine - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Infection/Fever | 82 Participants |
| Carbo/Gemcitabine - Carbo/Taxol | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Hepatic | 25 Participants |