Phase 2
N=62
Carboplatin Taxol Avastin in Ovarian Cancer (OVCA)
Ovarian Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00129727 ↗Enrolled (actual)
62
Serious AEs
14.5%
Results posted
Jun 2016
Primary outcome: Primary: PFS — 29.8 Months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Paclitaxel (Drug); Carboplatin (Drug); Bevacizumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PFS |
29.8 | — |
| SECONDARY Response Rate (RECIST-1) |
76 | — |
| SECONDARY Toxicity |
62 | — |
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 = 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 1.5 x upper limit of normal (ULN); SGOT > 5 x ULN.
- Calculated creatinine clearance 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.
Data sourced from ClinicalTrials.gov (NCT00129727). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.