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

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