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

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.

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