Carboplatin Taxol Avastin in Ovarian Cancer (OVCA) (NCT00129727) | Clinical Trial Compass
CompletedPhase 2
Carboplatin Taxol Avastin in Ovarian Cancer (OVCA)
62 participantsStarted 2005-06
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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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 in…