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

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.

Study Type: Interventional

Study Design: Treatment

Study Primary Completion Date: December 2011

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.

Intervention(s) in this Clinical Trial

• Drug: cisplatin
• Drug: sorafenib tosylate
• Drug: tamoxifen citrate
• Procedure: adjuvant therapy

Primary Measures

• Relapse-free survival
  • Safety Issue?: No
• Overall survival
  • Safety Issue?: No
• Toxicity
  • Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas

Overall Clinical Trial Officials and Contacts

Edward F. McClay, MD Principal Investigator San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00492505

Study ID Number: CDR0000551556

ClinicalTrials.gov Identifier: NCT00492505

Health Authority: Unspecified

Clinical trial summary from the National Cancer Institute's PDQ® database