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

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

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 + paclitaxel chemotherapy compared with carboplatin + paclitaxel chemotherapy alone in patients with previously untreated metastatic melanoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Albumin-Bound Paclitaxel; Bevacizumab; Carboplatin; Paclitaxel

Criteria

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