Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00323362
Status:
TERMINATED
Last Update Posted:
2014-05-22
First Post:
2006-03-07
Brief Title:
Gemcitabine and Imatinib Mesylate in Treating Patients With Recurrent or Metastatic Non-Small Cell Lung Cancer
Sponsor:
Rutgers The State University of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
Phase II Study of Imatinib Mesylate and Gemcitabine for RecurrentMetastatic Non-small Cell Lung Cancer NSCLC
Status:
TERMINATED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Toxicity
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 phase II trial is studying how well giving gemcitabine together with imatinib mesylate works in treating patients with recurrent or metastatic non-small cell lung cancer
PURPOSE This phase II trial is studying how well giving gemcitabine together with imatinib mesylate works in treating patients with recurrent or metastatic non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Evaluate the response rate in patients with recurrent or metastatic non-small cell lung cancer treated with gemcitabine hydrochloride and imatinib mesylate
Secondary
Assess time to progression in patients treated with this regimen
Assess overall survival and 1-year survival of patients treated with this regimen
Assess the toxicity of this regimen in these patients
OUTLINE This is a multicenter nonrandomized uncontrolled open-label study
Patients receive gemcitabine hydrochloride IV on days 3 and 10 and oral imatinib mesylate once daily on days 1-5 and 8-12 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 53 patients will be accrued for this study
Primary
Evaluate the response rate in patients with recurrent or metastatic non-small cell lung cancer treated with gemcitabine hydrochloride and imatinib mesylate
Secondary
Assess time to progression in patients treated with this regimen
Assess overall survival and 1-year survival of patients treated with this regimen
Assess the toxicity of this regimen in these patients
OUTLINE This is a multicenter nonrandomized uncontrolled open-label study
Patients receive gemcitabine hydrochloride IV on days 3 and 10 and oral imatinib mesylate once daily on days 1-5 and 8-12 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 53 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 |
|---|---|---|---|
| NJ1505 | OTHER | CINJ | httpsreporternihgovquickSearchP30CA072720 |
| P30CA072720 | NIH | None | None |
| 030503 | OTHER | None | None |
| 0220060014 | OTHER | None | None |