A Phase I/II Trial of Nexavar, Avastin and Eloxatin in Patients With Metastatic Malignant Melanoma
- To determine the maximum tolerated dose of sorafenib tosylate when administered with
bevacizumab and oxaliplatin.
- To determine the effect of this treatment regimen on the complete and partial response
rate in patients with metastatic melanoma.
- To determine the effect of this treatment regimen on the progression-free and overall
survival of patients with metastatic melanoma.
OUTLINE: This is a phase I dose-escalation study of sorafenib tosylate followed by a phase
- Phase I: Patients receive bevacizumab IV over 30-90 minutes and oxaliplatin IV over 2
hours on day 1. Patients also receive oral sorafenib tosylate twice daily on days 1-14.
Treatment repeats every 2 weeks in the absence of disease progression or unacceptable
- Phase II: Patients receive sorafenib tosylate at the maximum tolerated dose and
bevacizumab and oxaliplatin as in phase I.
After completion of study therapy, patients are followed for at least 5 years.
Primary Purpose: Treatment
Maximum tolerated dose of sorafenib tosylate when administered with bevacizumab and oxaliplatin
Edward F. McClay, MD
San Diego Pacific Oncology & Hematology Associates
|San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas||Encinitas, California 92024|