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
- Conditions
- LymphomaSmall Intestine CancerUnspecified Adult Solid Tumor, Protocol Specific
- Registration Number
- NCT00003368
- Lead Sponsor
- National Cancer Institute (NCI)
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (45)
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Ellis Fischel Cancer Center - Columbia
🇺🇸Columbia, Missouri, United States
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
CCOP - North Shore University Hospital
🇺🇸Manhasset, New York, United States
Veterans Affairs Medical Center - Syracuse
🇺🇸Syracuse, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
🇺🇸Syracuse, New York, United States
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
Veterans Affairs Medical Center - White River Junction
🇺🇸White River Junction, Vermont, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Veterans Affairs Medical Center - Richmond
🇺🇸Richmond, Virginia, United States
University of Tennessee, Memphis Cancer Center
🇺🇸Memphis, Tennessee, United States
Veterans Affairs Medical Center - Memphis
🇺🇸Memphis, Tennessee, United States
Veterans Affairs Medical Center - Birmingham
🇺🇸Birmingham, Alabama, United States
Veterans Affairs Medical Center - San Francisco
🇺🇸San Francisco, California, United States
UCSF Cancer Center and Cancer Research Institute
🇺🇸San Francisco, California, United States
Veterans Affairs Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Veterans Affairs Medical Center - Durham
🇺🇸Durham, North Carolina, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
MBCCOP - Massey Cancer Center
🇺🇸Richmond, Virginia, United States
University of California San Diego Cancer Center
🇺🇸La Jolla, California, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
CCOP - Christiana Care Health Services
🇺🇸Wilmington, Delaware, United States
University of Illinois at Chicago Health Sciences Center
🇺🇸Chicago, Illinois, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
🇺🇸Chicago, Illinois, United States
Veterans Affairs Medical Center - Togus
🇺🇸Togus, Maine, United States
Holden Comprehensive Cancer Center at The University of Iowa
🇺🇸Iowa City, Iowa, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
🇺🇸Baltimore, Maryland, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
🇺🇸Columbia, Missouri, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Norris Cotton Cancer Center
🇺🇸Lebanon, New Hampshire, United States
Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Veterans Affairs Medical Center - Buffalo
🇺🇸Buffalo, New York, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
New York Presbyterian Hospital - Cornell Campus
🇺🇸New York, New York, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Mount Sinai Medical Center, NY
🇺🇸New York, New York, United States
State University of New York - Upstate Medical University
🇺🇸Syracuse, New York, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Winston-Salem, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States