Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Objectives

1. 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.
2. Compare the toxicity of these regimens in these patients.

Entry Criteria

Disease Characteristics:

• Confirmed diagnosis of melanoma
  • High-risk, stage III disease
• No measurable metastatic disease
• Has undergone surgery within the past 8 weeks
  • Surgically rendered disease free

Prior/Concurrent Therapy:

• No prior tamoxifen citrate, sorafenib tosylate, or cisplatin
• No concurrent radiotherapy or surgery

Patient Characteristics:

• ECOG performance status 0-2
• Creatinine clearance ≥ 50 mL/min OR creatinine ≤ 1.5 mg/dL
• Liver function tests ≤ 3 times the upper limit of normal
• ANC ≥ 1,200/mm³
• Hemoglobin ≥ 9.0 g/dL
• Platelet count ≥ 100,000/mm³
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No myocardial infarction within the past 6 months
• No congestive heart failure requiring medication
• No pulmonary disease requiring supplemental oxygen
• No dyspnea at rest
• No active infection
• No chronic underlying immunodeficiency disease
• No other serious illness that, in the physicians’ opinion, may compromise the safety of the patient
• No other cancer within the past 5 years except for nonmelanoma skin cancer and cervical cancer
• No thromboembolic disease within the past 6 months

Expected Enrollment

Outcomes

Relapse-free survival
Overall survival
Toxicity

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.

Trial Contact Information

Trial Lead Organizations

San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas

Edward McClay, MD, Principal investigator		Ph: 760-452-3340 Email: emcclay@pacificoncology.com

U.S.A.
California
	Encinitas
	San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas
		Edward McClay, MD	Ph:  760-452-3340
			Email: emcclay@pacificoncology.com

Registry Information
Official Title		A Phase II Pilot Trial of Sorafenib, Tamoxifen and Cisplatin as Adjuvant Therapy for Patients with Stage III Malignant Melanoma
Trial Start Date		2007-04-16
Trial Completion Date		2011-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00492505
Date Submitted to PDQ		2007-05-15
Information Last Verified		2009-07-05

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