Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002759
Status:
COMPLETED
Last Update Posted:
2013-02-05
First Post:
1999-11-01
Brief Title:
Irinotecan Plus Cyclosporine and Phenobarbital in Treating Patients With Solid Tumors or Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A PHASE I STUDY OF IRINOTECAN CPT-11 WITH PHARMACOKINETIC MODULATION BY CYCLOSPORINE A AND PHENOBARBITAL
Status:
COMPLETED
Status Verified Date:
2006-05
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:
Phase I trial to study the effectiveness of irinotecan plus cyclosporine and phenobarbital in treating patients who have solid tumors or lymphoma that is refractory to standard therapy Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Cyclosporine and phenobarbital may enhance the effectiveness of irinotecan
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose of irinotecan CPT-11 when infused weekly with cyclosporine CYSP in patients with solid tumors or lymphoma refractory to standard therapy
II Determine whether CYSP modulates the pharmacokinetics and pharmacodynamics of CPT-11 and its active metabolite SN-38
III Determine whether phenobarbital modulates the pharmacokinetics and pharmacodynamics of CPT-11 and SN-38
OUTLINE This is a dose escalation study of irinotecan Patients are stratified according to gender
Part I Patients receive cyclosporine IV over 6 hours and irinotecan IV over 90 minutes weekly for 4 weeks Courses repeat every 6 weeks in the absence of unacceptable toxicity or disease progression Cohorts of 3-12 patients receive escalating doses of irinotecan until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which at least one third of patients experience dose limiting toxicity DLT
Part IIA If the DLT is diarrhea in part I then part IIA is opened Patients receive oral phenobarbital cyclosporine as in part I and irinotecan at the MTD from part I Dose escalation occurs as in part I to determine a new MTD If the DLT continues to be diarrhea the study is closed Part IIB If the DLT is neutropenia in part I then part IIB is opened Patients receive cyclosporine as in part I and escalating doses of irinotecan to determine a new MTD
Part III If the DLT is neutropenia in part IIA or any DLT in part IIB patients receive phenobarbital cyclosporine and irinotecan at the MTD determined as in part IIA or part IIB Dose escalation continues until a new MTD is determined
I Determine the maximum tolerated dose of irinotecan CPT-11 when infused weekly with cyclosporine CYSP in patients with solid tumors or lymphoma refractory to standard therapy
II Determine whether CYSP modulates the pharmacokinetics and pharmacodynamics of CPT-11 and its active metabolite SN-38
III Determine whether phenobarbital modulates the pharmacokinetics and pharmacodynamics of CPT-11 and SN-38
OUTLINE This is a dose escalation study of irinotecan Patients are stratified according to gender
Part I Patients receive cyclosporine IV over 6 hours and irinotecan IV over 90 minutes weekly for 4 weeks Courses repeat every 6 weeks in the absence of unacceptable toxicity or disease progression Cohorts of 3-12 patients receive escalating doses of irinotecan until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which at least one third of patients experience dose limiting toxicity DLT
Part IIA If the DLT is diarrhea in part I then part IIA is opened Patients receive oral phenobarbital cyclosporine as in part I and irinotecan at the MTD from part I Dose escalation occurs as in part I to determine a new MTD If the DLT continues to be diarrhea the study is closed Part IIB If the DLT is neutropenia in part I then part IIB is opened Patients receive cyclosporine as in part I and escalating doses of irinotecan to determine a new MTD
Part III If the DLT is neutropenia in part IIA or any DLT in part IIB patients receive phenobarbital cyclosporine and irinotecan at the MTD determined as in part IIA or part IIB Dose escalation continues until a new MTD is determined
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 |
|---|---|---|---|
| CDR0000064707 | REGISTRY | PDQ Physician Data Query | None |
| UCCRC-8033 | None | None | None |
| NCI-T95-0100H | None | None | None |