Carboplatin Taxol Avastin in Ovarian Cancer (OVCA)

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

Study Design: This ia a Phase II study.

Subjects: Patients with chemotherapy naive epithelial ovarian cancer; or fallopian, primary peritoneal and papillary serous mullerian tumors will be recruited.

Carboplatin and Taxol (paclitaxel) will be administered concurrently with bevacizumab after surgery for 6-8 cycles every 21 (q21) days. Bevacizumab will be omitted in the first cycle, immediately post-operatively. This will be followed by one year of bevacizumab q21.

Outcomes: Outcomes include toxicity, response rate, and progression free survival.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: Women and Infants Hospital of Rhode Island
• Treatments: Albumin-Bound Paclitaxel; Bevacizumab; Carboplatin; Paclitaxel

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.