A Single-Arm Study Evaluating Carboplatin/Gemcitabine in Combination With BSI-201 in Patients With Platinum-Sensitive Recurrent Ovarian Cancer

Inclusion Criteria: * At least 18 years of age * Histological diagnosis of epithelial ovarian carcinoma, fallopian tube cancer, or primary peritoneal carcinoma * Completion of only one previous course of chemotherapy which contained a platinum therapy, with sensitivity to that regimen. "Platinum-sensitivity" is defined by a relapse greater than 6 months after termination of platinum-based chemotherapy * Measurable disease, defined by at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded), and is ≥ 20 mm when measured by conventional techniques (palpation, plain x-ray, computed tomography \[CT\], or magnetic resonance imaging \[MRI\]) or ≥ 10 mm when measured by spiral CT * Adequate organ function defined as: absolute neutrophil count (ANC) ≥ 1,500/mm3, platelets ≥ 100,000/mm3, creatinine clearance \> 50mL/min, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 x upper limit of normal (ULN; or \< 5 x ULN in case of liver metastases); total bilirubin \< 1.5 mg/dL * For women of child bearing potential, documented negative pregnancy test within two weeks of study entry and agreement to acceptable birth control during the duration of the study therapy * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 * Signed, institutional review board (IRB) approved written informed consent Exclusion Criteria: * Concurrent invasive malignancy, not including: 1. Non-melanomatous skin cancer 2. In situ malignancies 3. Concurrent superficial endometrial carcinoma, if their endometrial carcinoma is superficial or invades less than 50% the thickness of the myometrium) 4. Low risk breast cancer (localized, non-inflammatory) treated with curative intent * Lesions identifiable only by positron emission tomography (PET) * Prior treatment with poly (ADP-ribose) polymerase (PARP) inhibitors, including BSI-201 * Major medical conditions that might affect study participation (i.e., uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection) * Other significant co-morbid condition which the investigator feels might compromise effective and safe participation in the study, including a history of congestive cardiac failure or an electrocardiogram (ECG) suggesting significant conduction defect or myocardial ischemia * Enrollment in another investigational device or drug study, or current treatment with other investigational agents * Concurrent radiation therapy to treat primary disease throughout the course of the study * Inability to comply with the requirements of the study * Pregnancy or lactation * Leptomeningeal disease or brain metastases requiring steroids or other therapeutic intervention