Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003368
Status:
COMPLETED
Last Update Posted:
2013-03-21
First Post:
1999-11-01
Brief Title:
Irinotecan in Treating Patients With Solid Tumors or Lymphoma Who Have Abnormal Liver or Kidney Function or Who Have Received Radiation Therapy to the Pelvis
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study of Irinotecan for Patients With Abnormal Liver or Renal Function or With Prior Pelvic Radiation Therapy
Status:
COMPLETED
Status Verified Date:
2006-07
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 Irinotecan may be effective in treating patients with abnormal liver or kidney function or who have received radiation therapy
PURPOSE Phase I trial to study the effectiveness of irinotecan in treating patients with solid tumors or lymphoma who have abnormal liver or kidney function or who have had previous radiation therapy to the pelvis
PURPOSE Phase I trial to study the effectiveness of irinotecan in treating patients with solid tumors or lymphoma who have abnormal liver or kidney function or who have had previous radiation therapy to the pelvis
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of irinotecan in patients with solid tumors or lymphoma who have liver or renal dysfunction or have had prior pelvic radiation II Characterize the pharmacokinetics of irinotecan in these patients
OUTLINE This is a dose escalation study Patients are stratified according to prior pelvic radiation therapy yes vs no Patients with no prior pelvic radiation are further stratified according to AST bilirubin and creatinine levels Patients receive irinotecan IV over 90 minutes every 3 weeks for a total of 2 courses After patients are reevaluated treatment may continue in the absence of disease progression or unacceptable toxicity Cohorts of 3 to 6 patients receive escalating doses of irinotecan Dose escalation proceeds within each stratum until the maximum tolerated dose MTD is determined The MTD is defined as the dose below that at which 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL Approximately 75 patients will be accrued for this study at a rate of 2-3 patients per month
OUTLINE This is a dose escalation study Patients are stratified according to prior pelvic radiation therapy yes vs no Patients with no prior pelvic radiation are further stratified according to AST bilirubin and creatinine levels Patients receive irinotecan IV over 90 minutes every 3 weeks for a total of 2 courses After patients are reevaluated treatment may continue in the absence of disease progression or unacceptable toxicity Cohorts of 3 to 6 patients receive escalating doses of irinotecan Dose escalation proceeds within each stratum until the maximum tolerated dose MTD is determined The MTD is defined as the dose below that at which 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL Approximately 75 patients will be accrued for this study at a rate of 2-3 patients per month
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 |
|---|---|---|---|
| CLB-9863 | US NIH GrantContract | None | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |