Carboplatin With or Without Gemcitabine in Treating Patients With Advanced Ovarian Epithelial Cancer That Has Not Responded to Previous Chemotherapy

AGO Study Group

Overview

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 if carboplatin is more effective with or without gemcitabine for ovarian epithelial cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin with or without gemcitabine in treating patients who have advanced ovarian epithelial cancer that has not responded to previous chemotherapy.

OBJECTIVES: * Compare time to progression in patients with advanced ovarian epithelial carcinoma who failed prior first-line platinum-based therapy when treated with carboplatin with or without gemcitabine. * Compare response rate, duration of response, and survival time of patients treated with these regimens. * Compare the toxicity of these treatment regimens in these patients. * Compare quality of life of patients treated with these regimens. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to progression-free time (6-12 months vs more than 12 months), type of prior first-line therapy, and bidimensionally measurable disease (yes vs no). Patients are randomized to one of two treatment arms. * Arm I: Patients receive carboplatin IV over 30-60 minutes on day 1 and gemcitabine IV over 30-60 minutes on days 1 and 8. * Arm II: Patients receive carboplatin IV as in arm I. Treatment in both arms repeats every 3 weeks for up to 6-8 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, before each subsequent chemotherapy course, and at 50 days after study. Patients are followed at 50 days, every 2 months for 1 year, and then every 3 months for 1 year. PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Conditions

Ovarian Cancer

Interventions

carboplatinDRUG

gemcitabine hydrochlorideDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically confirmed ovarian epithelial carcinoma not amenable to curative surgery or radiotherapy * Evidence of recurrence or progression 6 months after discontinuation of prior first-line platinum-containing regimen * No tumor of borderline malignancy * Evaluable disease outside previously irradiated area * No CNS metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 12 weeks Hematopoietic: * Neutrophil count at least 1,500/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Not specified Renal: * Glomerular filtration rate greater than 50 mL/min Other: * No concurrent active infection * No other primary malignancy except carcinoma in situ of the cervix or adequately treated basal cell skin cancer * No other concurrent serious systemic disorder PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * No more than 1 prior platinum-based chemotherapy regimen * No prior gemcitabine * No other concurrent cytotoxic or antineoplastic treatment Endocrine therapy: * At least 3 weeks since prior hormonal therapy * Concurrent hormone replacement therapy allowed * Concurrent steroid antiemetics allowed Radiotherapy: * See Disease Characteristics * At least 3 weeks since prior radiotherapy (limited to the small pelvis) * Concurrent palliative radiotherapy to nontarget lesions allowed Surgery: * See Disease Characteristics Other: * At least 3 weeks since other prior investigational agents

Locations (74)

Data from ClinicalTrials.gov

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St. Mary's/Duluth Clinic Health System

Duluth, Minnesota, United States

Tom Baker Cancer Center - Calgary

Calgary, Alberta, Canada

Cross Cancer Institute

Edmonton, Alberta, Canada

Lethbridge Cancer Clinic

Lethbridge, Alberta, Canada

British Columbia Cancer Agency - Centre for the Southern Interior

Kelowna, British Columbia, Canada

Nanaimo Cancer Clinic

Nanaimo, British Columbia, Canada

Penticton Regional Hospital

Penticton, British Columbia, Canada

British Columbia Cancer Agency - Fraser Valley Cancer Centre

Surrey, British Columbia, Canada

Prostate Centre at Vancouver General Hospital

Vancouver, British Columbia, Canada

British Columbia Cancer Agency

Vancouver, British Columbia, Canada

...and 64 more locations