A Study of Avastin (Bevacizumab) in Combination With Fotemustine in Patients With Metastatic Melanoma

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will investigate the efficacy and safety of bevacizumab + fotemustine in patients with stage IV melanoma, previously untreated with chemo- or immunotherapy for metastatic disease. Patients will receive Avastin (15mg/kg intravenously[IV]) on Day 1 of every 3 week cycle, in combination with fotemustine (100mg/m² IV) on Days 1, 8 and 15, followed by 4 weeks rest, followed by 100mg/m² IV every 3 weeks for 4-6 cycles. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

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

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Bevacizumab; Fotemustine

Criteria

Inclusion Criteria:

• cutaneous malignant melanoma;

• advanced, inoperable stage IV melanoma;

• measurable and/or evaluable sites of metastases.

Exclusion Criteria:

• prior chemotherapy and/or IFN/IL2 based immunotherapy for metastatic disease;

• prior malignancies within past 5 years, with the exception of cured non-melanoma skin cancer, or in situ cancer of cervix;

• clinically significant cardiovascular disease;

• ongoing treatment with aspirin (>325mg/day) or other medications known to predispose to gastrointestinal ulceration.