Clinical trial · Interventional
Carboplatin Taxol Avastin in Ovarian Cancer (OVCA)
Phase II Evaluation of Carboplatin, Paclitaxel and Bevacizumab as First Line Chemotherapy and Consolidation for Advanced Ovarian Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Phase II
- description
- Paclitaxel carboplatin bevacizumab
- interventionNames
- Drug: Paclitaxel
- Drug: Carboplatin
- Drug: Bevacizumab
Primary outcomes (1)
- measure
- PFS
- timeFrame
- Median PFS in months - up to 5 years
- description
- Progression Free Survival: To examine the toxicity, estimate the objective response rate, and progression free survival measured in months of carboplatin, paclitaxel, and bevacizumab followed by single agent bevacizumab as consolidation for advanced mullerian cancer
Secondary outcomes (2)
- measure
- Response Rate (RECIST-1)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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