Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00121251
Status:
COMPLETED
Last Update Posted:
2021-04-06
First Post:
2005-07-19
Brief Title:
Sorafenib Gemcitabine and Capecitabine in Treating Patients With Unresectable andor Metastatic Kidney Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Trial of BAY 43-9006 Plus Gemcitabine and Capecitabine in the Treatment of Patients With Advanced Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2021-03
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 phase III trial is studying the side effects and best dose of sorafenib gemcitabine and capecitabine and to see how well they work in treating patients with unresectable andor metastatic kidney cancer 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 gemcitabine and capecitabine 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 gemcitabine and capecitabine may kill more tumor cells
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose MTD and dose-limiting toxicity DLT of sorafenib administered in combination with gemictabine and capecitabine in patients with advanced renal cell carcinoma
II Determine the objective response rate for sorafenib in combination with gemictabine and capecitabine in patients with advanced renal cell carcinoma
III Determine the duration of overall survival and progression free survival in these patients
OUTLINE This is a multicenter non-randomized phase I dose-escalation study followed by a phase II study
PHASE I Patients receive sorafenib orally PO twice daily BID on days 1-21 gemcitabine intravenously IV over 30 minutes on days 1 and 8 and capecitabine PO BID on days 1-14 Treatment repeats every 21 days for at least 3 courses in the absence of unacceptable toxicity or disease progression
Cohorts of 3-6 patients receive escalating doses of sorafenib gemcitabine and capecitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity An additional 6 patients are treated at the MTD
Note Patients who complete at least 3 courses of treatment with objective response or stable disease but are deemed poor candidates for continued chemotherapy may continue treatment with sorafenib
PHASE II Patients receive sorafenib 200mg orally twice a day on days 1-21 gemcitabine 750 mgm2 intravenously on days 1 8 and capecitabine 415 mgm2 orally twice a day on days 1-14 of each 21 day cycle as in phase I at the MTD determined in phase I
After completion of study treatment patients are followed periodically
I Determine the maximum tolerated dose MTD and dose-limiting toxicity DLT of sorafenib administered in combination with gemictabine and capecitabine in patients with advanced renal cell carcinoma
II Determine the objective response rate for sorafenib in combination with gemictabine and capecitabine in patients with advanced renal cell carcinoma
III Determine the duration of overall survival and progression free survival in these patients
OUTLINE This is a multicenter non-randomized phase I dose-escalation study followed by a phase II study
PHASE I Patients receive sorafenib orally PO twice daily BID on days 1-21 gemcitabine intravenously IV over 30 minutes on days 1 and 8 and capecitabine PO BID on days 1-14 Treatment repeats every 21 days for at least 3 courses in the absence of unacceptable toxicity or disease progression
Cohorts of 3-6 patients receive escalating doses of sorafenib gemcitabine and capecitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity An additional 6 patients are treated at the MTD
Note Patients who complete at least 3 courses of treatment with objective response or stable disease but are deemed poor candidates for continued chemotherapy may continue treatment with sorafenib
PHASE II Patients receive sorafenib 200mg orally twice a day on days 1-21 gemcitabine 750 mgm2 intravenously on days 1 8 and capecitabine 415 mgm2 orally twice a day on days 1-14 of each 21 day cycle as in phase I at the MTD determined in phase I
After completion of study treatment patients are followed periodically
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 |
|---|---|---|---|
| P30CA013330 | NIH | CTEP | httpsreporternihgovquickSearchP30CA013330 |
| NCI-2009-00108 | REGISTRY | None | None |
| CDR0000434851 | None | None | None |
| 0501007709 | OTHER | None | None |
| 6981 | OTHER | None | None |
| N01CM62204 | NIH | None | None |