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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Melanoma (Skin)

Intervention / Treatment
-----------------
* Drug: cisplatin
* Drug: sorafenib tosylate
* Drug: tamoxifen citrate
* Procedure: adjuvant therapy


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cisplatin|nan|
|Drug: sorafenib tosylate|nan|
|Drug: tamoxifen citrate|nan|
|Procedure: adjuvant therapy|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse-free survival |  |  | 
| Overall survival |  |  | 
| Toxicity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage IIIA melanoma, stage IIIB melanoma, stage IIIC melanoma