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 iconNOT 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: No
Inclusion Criteria:
  1. - 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:
  1. - 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
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Investigator(s)

Harlan Pinto
Harlan Pinto
Medical oncologist, Head and neck specialist
Associate Professor of Medicine (Oncology) and of Otolaryngology - Head & Neck Surgery
Sunil Arani Reddy
Sunil Arani Reddy
Medical oncologist, Cutaneous oncology specialist
Clinical Associate Professor, Medicine - Oncology

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Contact

Sunil Arani Reddy
6507361234

View on ClinicalTrials.gov