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

- 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

- 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