A Single-Arm Study Evaluating Carboplatin/Gemcitabine in Combination With BSI-201 in Patients With Platinum-Resistant 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 resistance to that regimen. "Platinum-resistance" is defined by a relapse within 2 to 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:

• Non-melanomatous skin cancer
• In situ malignancies
• Concurrent superficial endometrial carcinoma, if their endometrial carcinoma is superficial or invades less than 50% the thickness of the myometrium)
• 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