Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005068
Status:
COMPLETED
Last Update Posted:
2011-08-03
First Post:
2000-04-06
Brief Title:
Combination Chemotherapy In Treating Patients With Metastatic or Unresectable Solid Tumors
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
A Phase I Study of Oxaliplatin CPT-11 5-FU and Leucovorin in Patients With Solid Tumors
Status:
COMPLETED
Status Verified Date:
2011-08
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 determine the effectiveness of two different regimens of combination chemotherapy in treating patients who have metastatic or unresectable solid tumors
PURPOSE Phase I trial to determine the effectiveness of two different regimens of combination chemotherapy in treating patients who have metastatic or unresectable solid tumors
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of irinotecan fluorouracil and leucovorin calcium Saltz regimen vs Mayo regimen plus oxaliplatin arm I vs arm II in patients with metastatic or unresectable solid tumors II Determine the effect of irinotecan on the disposition of oxaliplatin in these patients III Assess the development of peripheral neuropathy in these patients on the Mayo regimen IV Determine the activity of these regimens in patients with metastatic solid tumors
OUTLINE This is a dose escalation study Patients are entered to one of two treatment arms Arm I Saltz regimen Patients receive irinotecan IV over 90 minutes leucovorin calcium IV and fluorouracil IV on days 1 8 15 and 22 followed by oxaliplatin IV over 2 hours on days 1 and 15 Courses repeat every 6 weeks Arm II Mayo regimen Patients receive irinotecan IV over 90 minutes and oxaliplatin IV over 2 hours on day 1 followed by leucovorin calcium IV and fluorouracil IV over 90 minutes on days 2-5 Courses repeat every 3 weeks Cohorts of 3-6 patients receive escalating doses of fluorouracil one of two treatment doses for arm II and one of two treatment doses of irinotecan and oxaliplatin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity Patients are followed for 3 months
PROJECTED ACCRUAL Up to 60 patients will be accrued for this study within 8-14 months
OUTLINE This is a dose escalation study Patients are entered to one of two treatment arms Arm I Saltz regimen Patients receive irinotecan IV over 90 minutes leucovorin calcium IV and fluorouracil IV on days 1 8 15 and 22 followed by oxaliplatin IV over 2 hours on days 1 and 15 Courses repeat every 6 weeks Arm II Mayo regimen Patients receive irinotecan IV over 90 minutes and oxaliplatin IV over 2 hours on day 1 followed by leucovorin calcium IV and fluorouracil IV over 90 minutes on days 2-5 Courses repeat every 3 weeks Cohorts of 3-6 patients receive escalating doses of fluorouracil one of two treatment doses for arm II and one of two treatment doses of irinotecan and oxaliplatin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity Patients are followed for 3 months
PROJECTED ACCRUAL Up to 60 patients will be accrued for this study within 8-14 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 |
|---|---|---|---|
| 970109 | OTHER | Mayo Clinic Cancer Center | httpsreporternihgovquickSearchP30CA015083 |
| U01CA069912 | NIH | None | None |
| P30CA015083 | NIH | None | None |