Status:
COMPLETED
A Study of Bevacizumab With Carboplatin and Paclitaxel Chemotherapy for the First-Line Treatment of Patients With Metastatic Melanoma
Lead Sponsor:
Genentech, Inc.
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This Phase II, multicenter, randomized, double-blind, placebo-controlled trial was designed to estimate the efficacy and characterize the safety of bevacizumab when combined with carboplatin + paclita...
Eligibility Criteria
Inclusion
- Signed Informed Consent Form
- Age ≥ 18 years
- Metastatic melanoma (Stage IV)
- Histologically confirmed malignant melanoma with measurable or non-measurable disease
- Ability and willingness to comply with study and follow-up procedures
Exclusion
- Prior treatment for Stage IV disease with chemotherapy or biologic therapy such as interferon and interleukin-2
- Complete surgical resection or irradiation of all identifiable sites of disease at randomization
- Radiation therapy within 14 days prior to Day 1
- Prior therapy with bevacizumab, sorafenib, sunitinib, or other vascular endothelial growth factor (VEGF) pathway-targeted therapy
- Melanoma of ocular origin
- Known central nervous system (CNS) disease/brain metastases (history of brain disease or active disease)
- Life expectancy of \< 12 weeks
- Current, recent, or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study
- Inadequate organ function
- History of other malignancies within 5 years of Day 1, except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal cell carcinoma or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix
- Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications
- Inadequately controlled hypertension
- History of hypertensive crisis or hypertensive encephalopathy
- New York Heart Association (NYHA) Class II or greater CHF
- History of myocardial infarction or unstable angina within 6 months prior to Day 1
- History of stroke or transient ischemic attack within 6 months prior to Day 1
- Significant vascular disease (e.g., aortic aneurysm, aortic dissection) or recent peripheral arterial thrombosis within 6 months prior to Day 1
- History of hemoptysis within 1 month prior to Day 1
- Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 or anticipation of need for major surgical procedure during the course of the study
- Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1
- History of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1
- Serious, non-healing wound, active ulcer, or untreated bone fracture
- Known hypersensitivity to any component of bevacizumab
- Pregnancy (positive pregnancy test) or lactation
- Current, ongoing treatment with full-dose warfarin
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT00434252
Start Date
February 1 2007
End Date
April 1 2009
Last Update
July 18 2017
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