Sorafenib With Either Temsirolimus or Tipifarnib in Treating Patients With Stage IV Malignant Melanoma That Cannot Be Removed By Surgery

Phase 2

Completed

Brief Summary: This randomized phase II trial is studying how well giving sorafenib together with either temsirolimus or tipifarnib works in treating patients with stage IV melanoma that cannot be removed by surgery. Sorafenib, temsirolimus, and tipifarnib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib and tipifarnib may also stop the growth of tumor by blocking blood flow to the tumor. It is not yet known whether sorafenib is more effective when given together with temsirolimus or tipifarnib in treating patients with malignant melanoma.

Detailed Description: PRIMARY OBJECTIVES:

I. Compare the response rate (confirmed and unconfirmed and complete and partial) in patients with unresectable stage IV malignant melanoma treated with sorafenib in combination with either temsirolimus or tipifarnib.

II. Compare the 4-month progression-free survival rate of patients treated with these regimens.

III. Compare the safety and tolerability of these regimens, with an emphasis on long-term side effects and toxic effects, in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to metastatic (M) stage (M1a/b vs M1c). Patients are randomized to 1 of 2 treatment arms.

ARM I (reopened to accrual as of 8/15/2009): Patients receive oral sorafenib twice daily on days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.

ARM II (closed to accrual as of 8/15/2009): Patients receive oral sorafenib as in arm I and oral tipifarnib twice daily on days 1-21.

In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 3 years.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Arm II (sorafenib, tipifarnib)	sorafenib tosylate	Patients receive oral sorafenib as in arm I and oral tipifarnib twice daily on days 1-21
Arm I (sorafenib, temsirolimus)	sorafenib tosylate	Patients receive oral sorafenib twice daily on days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
Arm I (sorafenib, temsirolimus)	temsirolimus	Patients receive oral sorafenib twice daily on days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
Arm II (sorafenib, tipifarnib)	tipifarnib	Patients receive oral sorafenib as in arm I and oral tipifarnib twice daily on days 1-21

Primary Outcome Measures

Name	Time	Method
Response Rate (Complete and Partial)	Every 8 weeks until progression	Complete response corresponds to complete disappearance of all measurable and non-measurable lesions with no new lesions. Partial response corresponds to greater than or equal to 30ﬁ decrease of sum of longest diameter of all target measurable lesions with no new lesion and non unequivocal progression of non-measurable disease.
4-month Progression-free Survival	4 months after registration	Progression was defined as one or more of the following: 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed, unequivocal progression of non-measurable disease, appearance of any new lesions, death due to disease without prior documentation of progression and without symptomatic deterioration.

Secondary Outcome Measures

Name	Time	Method
Toxicity	Weekly during first cycle, every two weeks during the second cycle, and once a cycle further cycles (one cycle = 4 weeks).	Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event
One-year Overall Survival	One year after registration

Locations (173): University of Arkansas for Medical Sciences
🇺🇸
Little Rock, Arkansas, United States
East Bay Radiation Oncology Center
🇺🇸
Castro Valley, California, United States
Eden Hospital Medical Center
🇺🇸
Castro Valley, California, United States
Valley Medical Oncology Consultants-Castro Valley
🇺🇸
Castro Valley, California, United States
Valley Medical Oncology Consultants-Fremont
🇺🇸
Fremont, California, United States
University of Southern California/Norris Cancer Center
🇺🇸
Los Angeles, California, United States
Contra Costa Regional Medical Center
🇺🇸
Martinez, California, United States
El Camino Hospital
🇺🇸
Mountain View, California, United States
Highland General Hospital
🇺🇸
Oakland, California, United States
Alta Bates Summit Medical Center - Summit Campus
🇺🇸
Oakland, California, United States
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University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States