Melanoma Clinical Trial
Sorafenib, Tamoxifen, and Cisplatin in Treating Patients With High-Risk Stage III Melanoma
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.
Full 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.
Eligibility 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
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
PRIOR CONCURRENT THERAPY:
No prior tamoxifen citrate, sorafenib tosylate, or cisplatin
No concurrent radiotherapy or surgery
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There is 1 Location for this study
Encinitas California, 92024, United States More Info
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