A Phase II Pilot Trial of Sorafenib, Tamoxifen and Cisplatin as Adjuvant Therapy for Patients With Stage III Malignant Melanoma
- Compare relapse-free and overall survival of patients with high-risk stage III melanoma
receiving adjuvant sorafenib tosylate, tamoxifen citrate, and cisplatin vs historical
data from patients treated with tamoxifen citrate and cisplatin.
- Compare the toxicity of these regimens in these patients.
OUTLINE: This is a pilot study. Patients are stratified according to number of positive
lymph nodes identified during surgery.
Patients receive oral sorafenib tosylate twice daily on days 1-28, oral tamoxifen citrate
twice daily on days 1-7, and cisplatin IV over 1 hour on days 2 and 3. Treatment repeats
every 28 days for up to 4 courses in the absence of disease progression or unacceptable
After completion of study therapy, patients are followed periodically for at least 5 years.
Primary Purpose: Treatment
Edward F. McClay, MD
San Diego Pacific Oncology & Hematology Associates
|San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas||Encinitas, California 92024|