Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00281957
Status:
COMPLETED
Last Update Posted:
2014-05-20
First Post:
2006-01-24
Brief Title:
Sorafenib With Either Temsirolimus or Tipifarnib in Treating Patients With Stage IV Malignant Melanoma That Cannot Be Removed By Surgery
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 M1ab vs M1c Patients are randomized to 1 of 2 treatment arms
ARM I reopened to accrual as of 8152009 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 8152009 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
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 M1ab vs M1c Patients are randomized to 1 of 2 treatment arms
ARM I reopened to accrual as of 8152009 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 8152009 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA032102 | NIH | CTEP | httpsreporternihgovquickSearchU10CA032102 |
| NCI-2009-00774 | REGISTRY | None | None |
| S0438 | None | None | None |
| CDR0000454925 | None | None | None |
| S0438 | OTHER | None | None |
| S0438 | OTHER | None | None |