Carboplatin/Paclitaxel +/-Gemcitabine in Treating Patients With Ovarian Epithelial or Fallopian Tube Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether carboplatin and paclitaxel combined with gemcitabine is more effective than carboplatin and paclitaxel alone in treating ovarian epithelial or fallopian tube cancer. PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel combined with gemcitabine to see how well it works compared to paclitaxel and carboplatin alone in treating patients who have undergone surgery for ovarian epithelial or fallopian tube cancer.

Detailed Description
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OBJECTIVES: Compare overall survival in patients with stage I-IV ovarian epithelial or fallopian tube cancer treated with adjuvant carboplatin and paclitaxel with or without gemcitabine. Compare response rates, progression-free survival, and duration of response in patients treated with these regimens. Compare toxic effects of these regimens in these patients. Compare quality of life of patients treated with these regimens. OUTLINE: This is a randomized, open-label, controlled, multicenter study. Patients are stratified according to FIGO stage (I-IIA vs IIB-IIIC and tumor no greater than 10 mm vs IIB-IIIC and tumor greater than 10 mm or IV), plan for interval surgical debulking (yes vs no), and participating center. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive carboplatin IV over 30-60 minutes and paclitaxel IV over 3 hours on day 1 and gemcitabine IV over 30-60 minutes on days 1 and 8. Arm II: Patients receive carboplatin and paclitaxel as in arm I. Treatment in both arms repeats every 21 days for 6 to 10 courses in the absence of disease progression or unacceptable toxicity. Some patients undergo interval debulking surgery. Quality of life is assessed at baseline, after courses 3 and 6, and then at 3, 6, and 12 months after completion of study. Patients are followed every 3 months for 2 years, every 6 months for up to 5 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 1,716 patients (858 per treatment arm) will be accrued for this study within 2 years.

Official Title
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A Multi-National Randomized Phase-III GCIG Intergroup-Study Comparing 1st-line Chemotherapy With Gemcitabine/Paclitaxel/Carboplatin vs Paclitaxel/Carboplatin In Previously Untreated Patients With Epithelial Ovarian Cancer FIGO Stages I-IV

Conditions
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Fallopian Tube Cancer, Ovarian Cancer

Intervention / Treatment
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* Drug: TCG
* Drug: TC


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed diagnosis of one of the following: Ovarian epithelial cancer FIGO stage IA/B G3, IC-IV Fallopian tube cancer Extra-ovarian papillary serous tumor The following are ineligible: Low malignant-potential ovarian tumors (borderline tumors) Non-epithelial ovarian tumors Mixed Mullerian tumors Must have had definitive surgery within the past 6 weeks No symptomatic brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy At least 6 months Hematopoietic WBC at least 3,000/mm^3 OR Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin greater than 10 mg/dL Hepatic Bilirubin no greater than 2 times upper limit of normal Renal Glomerular filtration rate at least 50 mL/min Cardiovascular No congestive heart failure No myocardial infarction within the past 6 months No New York Heart Association class III or IV heart disease No prior atrial or ventricular arrhythmias Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior seizures or central nervous system disorder No prior severe hypersensitivity reaction to products containing Cremophor EL (e.g., cyclosporine or vitamin K) No known hypersensitivity to compounds chemically related to carboplatin, gemcitabine, or paclitaxel No preexisting motor or sensory neuropathy greater than grade 1 No other malignancy within the past 5 years except: Malignancies cured by surgery alone Carcinoma in situ of the cervix Adequately treated basal cell skin cancer No complete bowel obstruction No other concurrent severe medical condition that would preclude study participation No dementia or significantly altered mental status that would preclude study participation No concurrent severe active infection Geographically accessible for treatment and follow-up PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent immunotherapy Chemotherapy No prior chemotherapy No other concurrent chemotherapy Endocrine therapy No concurrent hormonal therapy except: Hormone replacement therapy Antiemetic steroids Radiotherapy No prior radiotherapy No concurrent radiotherapy Surgery See Disease Characteristics Recovered from prior surgery Other No other concurrent antineoplastic agents No other concurrent investigational drugs No other concurrent clinical trial enrollment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TCG<br>Paclitaxel 175 mg/m2 day 1, Carboplatin AUC 5 day 1, Gemcitabine 800 mg/m2 day 1 + 8, q 21 days / 6 - 10 courses | Drug: TCG<br> <br> * Other names: Paclitaxel/Carboplatin/Gemcitabine;|
| Active Comparator: TC<br>Paclitaxel 175 mg/m2 day 1, Carboplatin AUC 5 day 1, q 21 days / 6 - 10 courses | Drug: TC<br> <br> * Other names: Paclitaxel/Carboplatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Survival time is calculated from the date of enrollment into the study until the date of death from any cause | Whole Study Period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival | The progression-free survival is calculated for all patients from the date of enrollment until the date of first progressive disease or death, whichever occurs first | Whole Study Period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I ovarian epithelial cancer, stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, fallopian tube cancer