Sorafenib, Tamoxifen, and Cisplatin in Treating Patients With High-Risk Stage III Melanoma
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|ClinicalTrials.gov Identifier: NCT00492505|
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : June 27, 2007
Last Update Posted : January 10, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Drug: cisplatin Drug: sorafenib tosylate Drug: tamoxifen citrate Procedure: adjuvant therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Official Title:||A Phase II Pilot Trial of Sorafenib, Tamoxifen and Cisplatin as Adjuvant Therapy for Patients With Stage III Malignant Melanoma|
|Study Start Date :||April 2007|
|Estimated Primary Completion Date :||December 2011|
U.S. FDA Resources
- Relapse-free survival
- Overall survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00492505
|United States, California|
|San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas||Recruiting|
|Encinitas, California, United States, 92024|
|Contact: Edward F. McClay, MD 760-452-3340 email@example.com|
|Principal Investigator:||Edward F. McClay, MD||San Diego Pacific Oncology & Hematology Associates|