A Study of Bevacizumab With Carboplatin and Paclitaxel Chemotherapy for the First-Line Treatment of Patients With Metastatic Melanoma (BEAM)

Genentech

Status and phase

Completed

Phase 2

Conditions

Melanoma

Treatments

Drug: placebo

Drug: bevacizumab

Drug: paclitaxel

Drug: carboplatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00434252

AVF4096g

Details and patient eligibility

About

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.

Enrollment

214 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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