Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003710
Status:
COMPLETED
Last Update Posted:
2012-08-09
First Post:
1999-11-01
Brief Title:
Irinotecan Plus Mitomycin in Treating Patients With Advanced Solid Tumors
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
The University of Texas Health Science Center at San Antonio
Study Overview
Official Title:
Phase I and Pharmacokinetic Study of Sequentially Administered CPT-11 and Mitomycin C in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2012-06
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 irinotecan plus mitomycin in treating patients who have advanced solid tumors that are persistent or recurrent
PURPOSE Phase I trial to study the effectiveness of irinotecan plus mitomycin in treating patients who have advanced solid tumors that are persistent or recurrent
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of mitomycin when administered with irinotecan in patients with advanced solid tumors II Determine whether the pharmacokinetic profile of irinotecan is altered by prior administration of mitomycin in this patient population III Determine the effect of irinotecan and mitomycin on the expression of DT-Diaphorase and the Topo I gene IV Determine the preliminary antitumor activity of this regimen in these patients
OUTLINE This is a dose escalation study Patients receive mitomycin IV over 20 to 30 minutes on day 1 and irinotecan IV over 90 minutes on days 2 8 15 and 22 followed by 2 weeks of rest beginning on day 29 Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3 to 6 patients each receive escalating doses of mitomycin and irinotecan until the maximum tolerated dose MTD is reached The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity Patients are followed for 1 month
PROJECTED ACCRUAL Up to 30 patients will be accrued for this study
OUTLINE This is a dose escalation study Patients receive mitomycin IV over 20 to 30 minutes on day 1 and irinotecan IV over 90 minutes on days 2 8 15 and 22 followed by 2 weeks of rest beginning on day 29 Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3 to 6 patients each receive escalating doses of mitomycin and irinotecan until the maximum tolerated dose MTD is reached The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity Patients are followed for 1 month
PROJECTED ACCRUAL Up to 30 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 |
|---|---|---|---|
| NCI-V98-1504 | OTHER | NCI | httpsreporternihgovquickSearchP30CA054174 |
| P30CA054174 | NIH | None | None |
| UTHSC-9785011214 | OTHER | None | None |
| P-UPJOHN-966475090 | OTHER | None | None |
| SACI-IDD-98-01 | OTHER | None | None |