A Randomized Phase II Trial of BAY 43-9006 (Sorafenib; NSC-724772) With Either CCI-779 (Temsirolimus; NSC-683864) or R115777 (Tipifarnib; NSC-702818) in Metastatic Melanoma
Overview
- Phase
- Phase 2
- Intervention
- sorafenib tosylate
- Conditions
- Recurrent Melanoma
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 109
- Locations
- 173
- Primary Endpoint
- Response Rate (Complete and Partial)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Arm I (sorafenib, temsirolimus)
Patients receive oral sorafenib twice daily on days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
Intervention: sorafenib tosylate
Arm I (sorafenib, temsirolimus)
Patients receive oral sorafenib twice daily on days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
Intervention: temsirolimus
Arm II (sorafenib, tipifarnib)
Patients receive oral sorafenib as in arm I and oral tipifarnib twice daily on days 1-21
Intervention: sorafenib tosylate
Arm II (sorafenib, tipifarnib)
Patients receive oral sorafenib as in arm I and oral tipifarnib twice daily on days 1-21
Intervention: tipifarnib
Outcomes
Primary Outcomes
Response Rate (Complete and Partial)
Time Frame: 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
Time Frame: 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 Outcomes
- Toxicity(Weekly during first cycle, every two weeks during the second cycle, and once a cycle further cycles (one cycle = 4 weeks).)
- One-year Overall Survival(One year after registration)