Status:
COMPLETED
Carboplatin Taxol Avastin in Ovarian Cancer (OVCA)
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Women and Infants Hospital of Rhode Island
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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....
Detailed Description
Ovarian cancer is diagnosed in approximately 26,000 American women each year, and is the leading cause of death from gynecologic cancers. Difficult to detect, the disease typically presents only when ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00129727
Start Date
June 1 2005
End Date
February 1 2009
Last Update
June 1 2016
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