Carboplatin Taxol Avastin in Ovarian Cancer (OVCA)
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: Paclitaxel; Carboplatin; Bevacizumab
Intervention description: Given intravenously; Given intravenously; Given intravenously
Intervention MeSH terms: Paclitaxel; Bevacizumab; Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Carboplatin; Paclitaxel; Bevacizumab; Ovarian; Cancer

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.
    

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.