A Study of Bevacizumab With Carboplatin and Paclitaxel Chemotherapy for the First-Line Treatment of Patients With Metastatic Melanoma
Trial ID or NCT#
NCT00434252
Status
NOT RECRUITING
Purpose
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 + paclitaxel chemotherapy compared with carboplatin + paclitaxel chemotherapy alone in patients with previously untreated metastatic melanoma.
Official Title
A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Bevacizumab in Combination With Carboplatin and Paclitaxel Chemotherapy for the First-Line Treatment of Patients With Metastatic Melanoma
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
- * 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 Criteria:
- * 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
Investigator(s)
Sunil Arani Reddy
Medical oncologist,
Cutaneous oncology specialist
Clinical Associate Professor, Medicine - Oncology
Harlan Pinto
Medical oncologist,
Head and neck specialist
Associate Professor of Medicine (Oncology), Emeritus
Contact us to find out if this trial is right for you.
Contact
Sunil Arani Reddy
6507361234
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