Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004095
Status:
COMPLETED
Last Update Posted:
2017-04-18
First Post:
1999-12-10
Brief Title:
Irinotecan Plus Gemcitabine in Treating Patients With Unresectable or Metastatic Solid Tumors
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Phase I Trial of Irinotecan CPT-11 and Gemcitabine in Patients With Solid Tumors
Status:
COMPLETED
Status Verified Date:
2017-04
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 combining irinotecan and gemcitabine in treating patients who have unresectable or metastatic solid tumors
PURPOSE Phase I trial to study the effectiveness of combining irinotecan and gemcitabine in treating patients who have unresectable or metastatic solid tumors
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose MTD and the principal toxicities of irinotecan and gemcitabine in patients with surgically unresectable or metastatic solid tumors
Determine if the principal toxicities and MTD of this combination regimen are affected by drug sequencing in this patient population
Determine the potential for gemcitabine to alter the pharmacokinetic characteristics when administered with irinotecan in these patients
Describe the influence effected by varying the administration sequence of this combination regimen in this patient population
Obtain preliminary data regarding efficacy of this combination regimen in these patients
OUTLINE This is a dose-escalation study
Patients receive irinotecan IV over 90 minutes followed by gemcitabine IV over 30 minutes on days 1 and 15 Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity Once the maximum tolerated dose MTD is reached patients receive subsequent doses of the inverse sequence of the combination drugs until a new MTD is determined
Cohorts of 3-6 patients receive escalating doses of irinotecan and gemcitabine until the MTD is reached The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities
Patients are followed every 3 months until death
PROJECTED ACCRUAL At least 12 patients will be accrued for this study
Determine the maximum tolerated dose MTD and the principal toxicities of irinotecan and gemcitabine in patients with surgically unresectable or metastatic solid tumors
Determine if the principal toxicities and MTD of this combination regimen are affected by drug sequencing in this patient population
Determine the potential for gemcitabine to alter the pharmacokinetic characteristics when administered with irinotecan in these patients
Describe the influence effected by varying the administration sequence of this combination regimen in this patient population
Obtain preliminary data regarding efficacy of this combination regimen in these patients
OUTLINE This is a dose-escalation study
Patients receive irinotecan IV over 90 minutes followed by gemcitabine IV over 30 minutes on days 1 and 15 Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity Once the maximum tolerated dose MTD is reached patients receive subsequent doses of the inverse sequence of the combination drugs until a new MTD is determined
Cohorts of 3-6 patients receive escalating doses of irinotecan and gemcitabine until the MTD is reached The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities
Patients are followed every 3 months until death
PROJECTED ACCRUAL At least 12 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-G99-1588 | None | None | None |
| NU-98X3 | None | None | None |
| P-UPJOHN-976475157 | None | None | None |