Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006465
Status:
COMPLETED
Last Update Posted:
2010-06-11
First Post:
2000-11-06
Brief Title:
Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Phase I Study of Oxaliplatin NSC 266046 Irinotecan and Capecitabine in Patients With Solid Tumors
Status:
COMPLETED
Status Verified Date:
2010-06
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have advanced solid tumors
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose and dose-limiting toxicity of irinotecan and capecitabine when given in combination with a fixed dose of oxaliplatin in patients with advanced solid tumors
Determine the pharmacokinetic parameters of this regimen in these patients
Determine the antitumor response of these patients treated with this regimen
OUTLINE This is a dose-escalation study of irinotecan and capecitabine
Patients receive oxaliplatin IV over 2 hours followed 1 hour later by irinotecan IV over 30 minutes once weekly for 4 weeks Patients also receive oral capecitabine twice daily on days 1-5 weekly for 4 weeks Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of irinotecan 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
PROJECTED ACCRUAL Approximately 9-15 patients will be accrued for this study within 9-15 months
Determine the maximum tolerated dose and dose-limiting toxicity of irinotecan and capecitabine when given in combination with a fixed dose of oxaliplatin in patients with advanced solid tumors
Determine the pharmacokinetic parameters of this regimen in these patients
Determine the antitumor response of these patients treated with this regimen
OUTLINE This is a dose-escalation study of irinotecan and capecitabine
Patients receive oxaliplatin IV over 2 hours followed 1 hour later by irinotecan IV over 30 minutes once weekly for 4 weeks Patients also receive oral capecitabine twice daily on days 1-5 weekly for 4 weeks Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of irinotecan 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
PROJECTED ACCRUAL Approximately 9-15 patients will be accrued for this study within 9-15 months
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 |
|---|---|---|---|
| U01CA062502 | NIH | None | None |
| P30CA043703 | NIH | None | None |
| CWRU-5Y99 | OTHER | None | None |
| NCI-370 | Other Identifier | Case Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA043703 |