Carboplatin Taxol Avastin in Ovarian Cancer (OVCA)
Ovarian Cancer
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring Carboplatin, Paclitaxel, Bevacizumab, Ovarian, Cancer
Eligibility Criteria
Inclusion Criteria: Patients 18 years of age or older. Histological diagnosis of epithelial ovarian carcinoma, fallopian tube cancer, primary peritoneal carcinoma or papillary serous mullerian carcinoma. Previous attempted surgical debulking. Stage IC or greater. Performance status 0-2 by the ECOG scale. Peripheral neuropathy < grade 2. Life expectancy must be >= 6 months. Patients must be informed of the investigational nature of the study and sign an informed consent form. Exclusion Criteria: History of serious systemic disease, including: myocardial infarction within the last 6 months; uncontrolled hypertension (blood pressure of >160/110 mmHg on medication); unstable angina; New York Heart Association (NYHA) Grade II or greater congestive heart failure; unstable symptomatic arrhythmia requiring medication (subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia are eligible); or peripheral vascular disease (Grade II or greater). Prior history of thrombotic events and stroke are also included as exclusion criteria. Neutrophil count <1,500/mm3; platelet count <100,000/m3. Alkaline phosphatase or bilirubin > 1.5 x upper limit of normal (ULN); SGOT > 5 x ULN. Calculated creatinine clearance < 50 ml/min. Prior chemotherapy or radiotherapy. Inadequate surgical cytoreduction such that interval cytoreductive surgery could materially improve prognosis. Patients are not permitted to have interval cytoreductive surgery on study. Concurrent invasive malignancy. (Patients with concurrent superficial endometrioid endometrial carcinoma are eligible, if their endometrial carcinoma is superficial or invades less than 50% of the thickness of the myometrium.) Uncontrolled hypertension (defined as a Grade 4 event that has failed to resolve with observation or treatment) or bleeding diathesis. Evidence of tumor involving major blood vessels on any prior computed tomography (CT) scan. Surgical wound that has failed to close. Prior treatment with an anti-angiogenic agent. Any active bleeding. Therapeutic anticoagulation (prophylactic very low dose warfarin is allowed [1mg by mouth (p.o.) once daily (qd) with International Normalized Ratio (INR) <1.2]). Active psychiatric disease or neurologic symptoms requiring treatment (Grade I sensory neuropathy allowed). Presence of central nervous system or brain metastases. Proteinuria at baseline or clinically significant impairment of renal function. Subjects unexpectedly discovered to have > 1+ proteinuria at baseline should undergo a 24-hour urine collection, which must be an adequate collection and must demonstrate < 1g of protein/24 hr to allow participation in the study. Dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent. Patients with known hypersensitivity to Cremophor EL. Patients with active bacterial, viral or fungal infections Patients receiving other investigational therapy.
Sites / Locations
Arms of the Study
Arm 1
Experimental
Phase II
Paclitaxel carboplatin bevacizumab