Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00483366
Status:
COMPLETED
Last Update Posted:
2023-09-14
First Post:
2007-06-06
Brief Title:
Imatinib Mesylate Gemcitabine and Capecitabine in Treating Patients With Advanced Solid Tumors
Sponsor:
University of Nebraska
Organization:
University of Nebraska
Study Overview
Official Title:
Phase I Study of Imatinib Gemcitabine and Capecitabine in Patients With Solid Tumors
Status:
COMPLETED
Status Verified Date:
2024-09
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:
RATIONALE Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth 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 imatinib mesylate together with gemcitabine and capecitabine may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of gemcitabine and capecitabine when given together with imatinib mesylate in treating patients with advanced solid tumors
PURPOSE This phase I trial is studying the side effects and best dose of gemcitabine and capecitabine when given together with imatinib mesylate in treating patients with advanced solid tumors
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose of gemcitabine hydrochloride and capecitabine when combined with imatinib mesylate in patients with advanced solid tumors
Determine the toxicity of this regimen in these patients
Secondary
Explore the antitumor activity of this regimen in these patients
OUTLINE This is a dose-escalation study of gemcitabine and capecitabine
Patients receive oral imatinib mesylate once daily on days 1-5 and 8-12 gemcitabine hydrochloride IV on days 3 and 10 and oral capecitabine twice daily on days 1-14 Treatment repeats every 21 days for at least 2 courses in the absence of progressive disease or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of gemcitabine hydrochloride and capecitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Existing paraffin-embedded tissue blocks from patients diagnosed with melanoma or renal cell carcinoma will be assessed for c-kit mutations by polymerase chain reaction and direct sequencing of both juxtamembrane domains exons 9 and 11 and tyrosine kinase domain exon 13 and 17 Begins 12-11-2008
PROJECTED ACCRUAL Closed to patient accrual 12112008
Primary
Determine the maximum tolerated dose of gemcitabine hydrochloride and capecitabine when combined with imatinib mesylate in patients with advanced solid tumors
Determine the toxicity of this regimen in these patients
Secondary
Explore the antitumor activity of this regimen in these patients
OUTLINE This is a dose-escalation study of gemcitabine and capecitabine
Patients receive oral imatinib mesylate once daily on days 1-5 and 8-12 gemcitabine hydrochloride IV on days 3 and 10 and oral capecitabine twice daily on days 1-14 Treatment repeats every 21 days for at least 2 courses in the absence of progressive disease or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of gemcitabine hydrochloride and capecitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Existing paraffin-embedded tissue blocks from patients diagnosed with melanoma or renal cell carcinoma will be assessed for c-kit mutations by polymerase chain reaction and direct sequencing of both juxtamembrane domains exons 9 and 11 and tyrosine kinase domain exon 13 and 17 Begins 12-11-2008
PROJECTED ACCRUAL Closed to patient accrual 12112008
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 |
|---|---|---|---|
| P30CA036727 | NIH | None | httpsreporternihgovquickSearchP30CA036727 |