Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00074321
Status:
COMPLETED
Last Update Posted:
2013-06-06
First Post:
2003-12-10
Brief Title:
Irinotecan Oxaliplatin and Capecitabine in Treating Patients With Unresectable Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I And Pharmacogenetic Study Of CPT-11 Oxaliplatin And Capecitabine In Patients With Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-06
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:
Drugs used in chemotherapy such as irinotecan oxaliplatin and capecitabine work in different ways to stop tumor cells from dividing so they stop growing or die Combining more than one chemotherapy drug may kill more tumor cells This phase I trial is studying the side effects and best dose of irinotecan oxaliplatin and capecitabine in treating patients with unresectable solid tumors
Detailed Description:
OBJECTIVES
I To define the maximally tolerated dose of the combination of CPT-11 irinotecan hydrochloride oxaliplatin and capecitabine in three different populations based on UDP glucuronosyltransferase 1 family polypeptide A1 UGT1A1 genotype 66 67 and 77
II To identify any activity of this treatment combination in patients with metastatic cancer
III To examine the differences in the toxicity profile especially pertaining to hematologic and gastrointestinal GI and the maximally tolerated dose of the combination of CPT-11 oxaliplatin and capecitabine with respect to the UGT1A1 haplotypes
IV Examine the effect of the UGT1A1 genotype on the pharmacokinetics of CPT-11 and its metabolites
OUTLINE This is a dose-escalation study Patients are stratified according to UGT1A1 genotype 66 vs 67 closed to accrual as of 82406 vs 77
Patients receive irinotecan hydrochloride intravenously IV over 90 minutes and oxaliplatin IV over 2 hours on day 1 and capecitabine orally PO twice daily QD on days 2-15 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of irinotecan hydrochloride oxaliplatin 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 Once the MTD is determined an additional 6-10 patients for a total of 12 patients receive treatment at that dose
After completion of study treatment patients are followed up at 3 months
PROJECTED ACCRUAL A total of 54-84 patients 12-22 for stratum I 18-28 for stratum II closed to accrual as of 82406 and 24-34 for stratum III will be accrued for this study within approximately 44 years
I To define the maximally tolerated dose of the combination of CPT-11 irinotecan hydrochloride oxaliplatin and capecitabine in three different populations based on UDP glucuronosyltransferase 1 family polypeptide A1 UGT1A1 genotype 66 67 and 77
II To identify any activity of this treatment combination in patients with metastatic cancer
III To examine the differences in the toxicity profile especially pertaining to hematologic and gastrointestinal GI and the maximally tolerated dose of the combination of CPT-11 oxaliplatin and capecitabine with respect to the UGT1A1 haplotypes
IV Examine the effect of the UGT1A1 genotype on the pharmacokinetics of CPT-11 and its metabolites
OUTLINE This is a dose-escalation study Patients are stratified according to UGT1A1 genotype 66 vs 67 closed to accrual as of 82406 vs 77
Patients receive irinotecan hydrochloride intravenously IV over 90 minutes and oxaliplatin IV over 2 hours on day 1 and capecitabine orally PO twice daily QD on days 2-15 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of irinotecan hydrochloride oxaliplatin 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 Once the MTD is determined an additional 6-10 patients for a total of 12 patients receive treatment at that dose
After completion of study treatment patients are followed up at 3 months
PROJECTED ACCRUAL A total of 54-84 patients 12-22 for stratum I 18-28 for stratum II closed to accrual as of 82406 and 24-34 for stratum III will be accrued for this study within approximately 44 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 |
|---|---|---|---|
| MAYO-MC0311 | None | None | None |
| MC0311 | None | None | None |
| NCI-6240 | None | None | None |
| CDR0000344367 | None | None | None |