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

Melanoma (Skin) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00492505
• Other study ID #: CDR0000551556
• Secondary ID: POHA-0602
• Status: Recruiting
• Phase: Phase 2
• First received: June 25, 2007
• Last updated: January 9, 2014
• Start date: April 2007

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Drug:
• cisplatin

• sorafenib tosylate

• tamoxifen citrate

Procedure:
• adjuvant therapy

Locations

Country	Name	City	State
United States	San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas	Encinitas	California

Sponsors (1)

Lead Sponsor	Collaborator
San Diego Pacific Oncology & Hematology Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse-free survival			No
Primary	Overall survival			No
Primary	Toxicity			Yes