Gemcitabine Plus Carboplatin Versus Carboplatin Monotherapy in Patients With Advanced Ovarian Cancer

AGO Study Group

Status and phase

Completed

Phase 3

Conditions

Ovarian Cancer

Treatments

Drug: Gemcitabine

Study type

Interventional

Funder types

Other

Identifiers

NCT00102414

AGO-OVAR 2.5

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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