Sorafenib With Either Temsirolimus or Tipifarnib in Treating Patients With Stage IV Malignant Melanoma That Cannot Be Removed By Surgery
|Recurrent Melanoma Stage IV Melanoma||Drug: sorafenib tosylate Drug: tipifarnib Drug: temsirolimus||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- 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.
- One-year Overall Survival [ Time Frame: One year after registration ]
- Toxicity [ Time Frame: 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
|Study Start Date:||August 2007|
|Study Completion Date:||January 2011|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Experimental: 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.
Drug: sorafenib tosylate
Other Names:Drug: temsirolimus
Experimental: Arm II (sorafenib, tipifarnib)
Patients receive oral sorafenib as in arm I and oral tipifarnib twice daily on days 1-21
Drug: sorafenib tosylate
Other Names:Drug: tipifarnib
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00281957
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|Principal Investigator:||Kim Margolin||Southwest Oncology Group|