Melanoma (Skin) Clinical Trial
Official title:
A Phase II Pilot Trial of Sorafenib, Tamoxifen and Cisplatin as Adjuvant Therapy for Patients With Stage III Malignant Melanoma
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,
such as tamoxifen and cisplatin, work in different ways to stop the growth of tumor cells,
either by killing the cells or by stopping them from dividing. Giving sorafenib together
with tamoxifen and cisplatin after surgery may kill any tumor cells that remain after
surgery.
PURPOSE: This phase II trial is studying the side effects and how well giving sorafenib
together with tamoxifen and cisplatin works in treating patients with high-risk stage III
melanoma.
OBJECTIVES:
- 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
toxicity.
After completion of study therapy, patients are followed periodically for at least 5 years.
;
Primary Purpose: Treatment
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