Ignite Creation Date:
2024-05-05 @ 10:18 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002939
Status:
COMPLETED
Last Update Posted:
2013-09-05
First Post:
1999-11-01
Brief Title:
Irinotecan and Paclitaxel in Treating Patients With Metastatic or Recurrent Cancer
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
A Phase I Trial of Dose Escalated Irinotecan CPT-11 With Paclitaxel in Patients With Metastatic or Recurrent Malignancies
Status:
COMPLETED
Status Verified Date:
2013-09
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 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 and paclitaxel in treating patients with metastatic or recurrent cancer
PURPOSE Phase I trial to study the effectiveness of irinotecan and paclitaxel in treating patients with metastatic or recurrent cancer
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose MTD of irinotecan administered in combination with paclitaxel in patients with metastatic or recurrent malignancies II Evaluate the toxicity and safety of this combination regimen in this patient population III Determine the pharmacokinetic profile of irinotecan in combination with paclitaxel on a weekly schedule and if the sequence of administration influences irinotecan pharmacokinetics in these patients IV Determine pharmacodynamic models of irinotecan and its SN-38 and SN-38G metabolites when administered in this weekly combination schedule
OUTLINE This is a dose escalation study of irinotecan Patients receive irinotecan IV concurrently with paclitaxel IV weekly Patients demonstrating stable disease or partial or complete clinical response continue with treatment as long as dose limiting toxicities are not observed and adequate performance status is maintained Cohorts of 3 patients receive escalating doses of irinotecan until the maximum tolerated dose is determined or 150 mgm2 is reached
PROJECTED ACCRUAL A total of 36 patients will be accrued for this study
OUTLINE This is a dose escalation study of irinotecan Patients receive irinotecan IV concurrently with paclitaxel IV weekly Patients demonstrating stable disease or partial or complete clinical response continue with treatment as long as dose limiting toxicities are not observed and adequate performance status is maintained Cohorts of 3 patients receive escalating doses of irinotecan until the maximum tolerated dose is determined or 150 mgm2 is reached
PROJECTED ACCRUAL A total of 36 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-G97-1166 | None | None | None |
| UCCRC-8380 | None | None | None |