NCT00492505

Sorafenib, Tamoxifen, and Cisplatin in Treating Patients With High-Risk Stage III Melanoma

A Phase II Pilot Trial of Sorafenib, Tamoxifen and Cisplatin as Adjuvant Therapy for Patients With Stage III Malignant Melanoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: San Diego Pacific Oncology & Hematology Associates · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
DRUG	cisplatin
DRUG	sorafenib tosylate
DRUG	tamoxifen citrate
PROCEDURE	adjuvant therapy

Timeline

• Start date: 2007-04-01
• Primary completion: 2011-12-01
• First posted: 2007-06-27
• Last updated: 2014-01-10

Locations

1 site across 1 country: United States