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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: San Diego Pacific Oncology & Hematology Associates
• Treatments: Cisplatin; Sorafenib; Tamoxifen

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