A Randomized Phase III Study Comparing Gemcitabine Plus Carboplatin Versus Carboplatin Monotherapy in Patients With Advanced Epithelial Ovarian Carcinoma Who Failed First-Line Platinum-Based Therapy

AGO Study Group0 sites356 target enrollmentSeptember 1999

ConditionsOvarian Cancer

DrugsGemcitabine

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Ovarian Cancer
Sponsor: AGO Study Group
Enrollment: 356
Primary Endpoint: Time to progressive disease
Status: Completed
Last Updated: 19 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The primary objective of this study is to compare the time to progressive disease in patients treated with gemcitabine plus carboplatin versus carboplatin monotherapy. Patients will have advanced epithelial ovarian cancer and have failed first-line platinum-containing therapy 6 months after treatment discontinuation.

Detailed Description

Carboplatin is commonly used for the treatment of ovarian cancer in first- and second-line therapy. The efficacy of gemcitabine in ovarian carcinoma was researched in various Phase 2 studies.

Registry

clinicaltrials.gov

Start Date

September 1999

End Date

November 2004

Last Updated

19 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

AGO Study Group

Eligibility Criteria

Inclusion Criteria

•Histologically proven ovarian cancer with evidence of recurrence or progression
•Failed first-line platinum containing therapy after 6 months of treatment discontinuation
•Documented lesion as evidenced by appropriate computerized tomography (CT), magnetic resonance imaging (MRI) scan, chest x-ray, or ultrasound.
•Previous hormonal therapy or radiotherapy must be terminated at least 3 weeks before study drug administration
•Adequate bone marrow reserve: neutrophils ≥ 1.5 x 10\^9/L and platelets ≥ 100 x 10\^9/L

Exclusion Criteria

•Receiving concomitant cytotoxic or other antineoplastic treatment. Hormone replacement therapy is allowed, as are steroid antiemetics
•Clinical evidence of central nervous system metastases
•Active infection
•Cannot adequately be followed up for the duration of the study
•A second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
•Use of any investigational agent in the 3 weeks prior to inclusion
•Serious concomitant systematic disorders incompatible with the study
•Received more than one previous chemotherapy regimen or had prior gemcitabine treatment
•Patients with tumor of borderline malignancy
•Patients with estimated GFR ≤ 50 mL/min