Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00323791
Status:
TERMINATED
Last Update Posted:
2009-12-11
First Post:
2006-05-08
Brief Title:
Gemcitabine With or Without Imatinib Mesylate in Treating Patients With Metastatic or Unresectable Kidney Cancer
Sponsor:
University of Medicine and Dentistry of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
A Phase II Trial of Gemzar Gemcitabine and Gleevec Imatinib Mesylate in Patients With Metastatic Renal Cell Carcinoma
Status:
TERMINATED
Status Verified Date:
2009-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as gemcitabine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Giving gemcitabine together with imatinib mesylate may kill more tumor cells
PURPOSE This randomized phase II trial is studying gemcitabine and imatinib mesylate to see how well they work compared with gemcitabine alone in treating patients with metastatic or unresectable kidney cancer
PURPOSE This randomized phase II trial is studying gemcitabine and imatinib mesylate to see how well they work compared with gemcitabine alone in treating patients with metastatic or unresectable kidney cancer
Detailed Description:
OBJECTIVES
Primary
Compare stable disease and objective response in patients with metastatic or unresectable renal cell carcinoma treated with gemcitabine hydrochloride with or without imatinib mesylate
Secondary
Evaluate the median survival progression-free survival and response rate in patients treated with gemcitabine hydrochloride and imatinib mesylate
Determine the qualitative and quantitative toxic effects of this regimen in these patients
Determine the expression of c-KIT and platelet-derived growth factor receptor-alpha protein expression in both tumor cells and associated endothelial cells using immunohistochemistry staining of paraffin-embedded tissue
OUTLINE This is a randomized multicenter study Patients are stratified by histology clear cell vs nonclear cell and prior therapy immunotherapychemotherapy vs targeted agents
Patients receive gemcitabine hydrochloride IV on days 3 and 10 and oral imatinib mesylate on days 1-5 and 8-12 Treatment repeats every 21 days for up to 2 courses in the absence of disease progression or unacceptable toxicity Patients achieving partial or complete response after 2 courses of treatment continue treatment with gemcitabine hydrochloride and imatinib mesylate in the absence of disease progression or unacceptable toxicity Patients with stable disease after 2 courses of treatment are randomized to 1 of 2 treatment arms
Arm I Patients receive gemcitabine hydrochloride IV on days 3 and 10
Arm II Patients receive gemcitabine hydrochloride IV on days 3 and 10 and oral imatinib mesylate on days 1-5 and 8-12
In both arms treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity
Available archived tumor tissue samples are obtained for immunohistochemical analysis to quantify the expression of c-KIT and platelet-derived growth factor receptor-alpha protein expression
After completion of study treatment patients are followed every 3 months
PROJECTED ACCRUAL A total of 100 patients will be accrued for this study
Primary
Compare stable disease and objective response in patients with metastatic or unresectable renal cell carcinoma treated with gemcitabine hydrochloride with or without imatinib mesylate
Secondary
Evaluate the median survival progression-free survival and response rate in patients treated with gemcitabine hydrochloride and imatinib mesylate
Determine the qualitative and quantitative toxic effects of this regimen in these patients
Determine the expression of c-KIT and platelet-derived growth factor receptor-alpha protein expression in both tumor cells and associated endothelial cells using immunohistochemistry staining of paraffin-embedded tissue
OUTLINE This is a randomized multicenter study Patients are stratified by histology clear cell vs nonclear cell and prior therapy immunotherapychemotherapy vs targeted agents
Patients receive gemcitabine hydrochloride IV on days 3 and 10 and oral imatinib mesylate on days 1-5 and 8-12 Treatment repeats every 21 days for up to 2 courses in the absence of disease progression or unacceptable toxicity Patients achieving partial or complete response after 2 courses of treatment continue treatment with gemcitabine hydrochloride and imatinib mesylate in the absence of disease progression or unacceptable toxicity Patients with stable disease after 2 courses of treatment are randomized to 1 of 2 treatment arms
Arm I Patients receive gemcitabine hydrochloride IV on days 3 and 10
Arm II Patients receive gemcitabine hydrochloride IV on days 3 and 10 and oral imatinib mesylate on days 1-5 and 8-12
In both arms treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity
Available archived tumor tissue samples are obtained for immunohistochemical analysis to quantify the expression of c-KIT and platelet-derived growth factor receptor-alpha protein expression
After completion of study treatment patients are followed every 3 months
PROJECTED ACCRUAL A total of 100 patients will be accrued for this study
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 |
|---|---|---|---|
| P30CA072720 | NIH | None | None |
| CINJ-080507 | None | None | None |
| CINJ-5633 | None | None | None |
| CINJ-NJ3805 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA072720 |