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
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00003368|
Recruitment Status : Completed
First Posted : March 12, 2004
Last Update Posted : March 21, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific||Drug: irinotecan hydrochloride||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase I Study of Irinotecan for Patients With Abnormal Liver or Renal Function or With Prior Pelvic Radiation Therapy|
|Study Start Date :||June 1998|
|Actual Study Completion Date :||July 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003368
|Study Chair:||Alan P. Venook, MD||University of California, San Francisco|