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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase II Pilot Study of Adjuvant Sorafenib Tosylate, Tamoxifen Citrate, and Cisplatin in Patients With High-Risk Stage III Malignant Melanoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	18 and over	Other	POHA-0602 06-02, NCT00492505

Trial Description

Purpose:

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.

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.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• No measurable metastatic cancer
• No more than 8 weeks since surgery to remove the tumor
• No previous tamoxifen, sorafenib, or cisplatin
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will receive sorafenib by mouth twice a day for 4 weeks. They will also receive tamoxifen by mouth twice a day for 1 week and a 1-hour infusion of cisplatin on days 2 and 3. Treatment may repeat every 4 weeks for up to four courses.

After finishing treatment, patients will be evaluated periodically for at least 5 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas

Edward McClay, MD, Principal investigator		Ph: 760-452-3340 Email: emcclay@pacificoncology.com

U.S.A.
California
	Encinitas
	San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas
		Edward McClay, MD	Ph:  760-452-3340
			Email: emcclay@pacificoncology.com

Registry Information
Official Title		A Phase II Pilot Trial of Sorafenib, Tamoxifen and Cisplatin as Adjuvant Therapy for Patients with Stage III Malignant Melanoma
Trial Start Date		2007-04-16
Trial Completion Date		2011-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00492505
Date Submitted to PDQ		2007-05-15
Information Last Verified		2009-07-05

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