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Irinotecan in Treating Aging Patients With Solid Tumors



Irinotecan in Treating Aging Patients With Solid Tumors

For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): Cancer and Leukemia Group B , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Aging may affect the way these drugs work. PURPOSE: Phase I trial to determine the relationship between aging and the effectiveness of irinotecan in treating patients who have solid tumors.
Details: OBJECTIVES: - Determine whether there is a relationship between the pharmacokinetic characteristics of irinotecan and aging in patients with non-hematologic malignancies. - Determine whether there is a relationship between the toxic effects of this drug and aging in these patients. - Determine whether the relationship between genotype (UGT1A1, CYP3A, and other relevant genes) and phenotype (pharmacokinetics, toxicity) is affected by aging in these patients treated with this drug. - Analyze data collected on the co-morbid conditions and concurrent medications in these patients treated with this drug. OUTLINE: This is a multicenter study. Patients are stratified according to age (18 to 55 vs 70 and over). Patients receive irinotecan IV over 90 minutes once weekly for 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed for survival. PROJECTED ACCRUAL: A total of 140 patients (70 per stratum) will be accrued for this study within 3.5 years.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed non-hematologic malignancy - Brain metastases or primary brain tumors are eligible provided patient is not receiving steroids or antiepileptic medications PATIENT CHARACTERISTICS: Age: - 18 to 55 or 70 and over Performance status: - CTC 0-2 Life expectancy: - Not specified Hematopoietic: - Granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than upper limit of normal (ULN) - SGOT no greater than ULN Renal: - Creatinine no greater than ULN Other: - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for nitrosourea) - No more than 1 prior chemotherapy regimen for metastatic disease (no limit if administered in the adjuvant setting) - No prior camptothecin Endocrine therapy: - See Disease Characteristics Radiotherapy: - At least 4 weeks since prior radiotherapy - No concurrent radiotherapy, including for palliation Surgery: - At least 4 weeks since prior major surgery
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
StuartLichtman,  Study Chair,  North Shore University Hospital

Mount Sinai Medical Center, NY
New York City,  New York,  10029
United States
 

Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia,  Missouri,  65201
United States
 

University of Nebraska Medical Center
Omaha,  Nebraska,  68198-7680
United States
 

CCOP - Southern Nevada Cancer Research Foundation
Las Vegas,  Nevada,  89106
United States
 

Veterans Affairs Medical Center - Buffalo
Buffalo,  New York,  14215
United States
 

CCOP - Southeast Cancer Control Consortium
Winston Salem,  North Carolina,  27104-4241
United States
 

Roswell Park Cancer Institute
Buffalo,  New York,  14263-0001
United States
 

CCOP - Christiana Care Health Services
Wilmington,  Delaware,  19899
United States
 

Missouri Baptist Cancer Center
St. Louis,  Missouri,  63131
United States
 

North Shore University Hospital
Manhasset,  New York,  11030
United States
 

Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore,  Maryland,  21201
United States
 

Arthur G. James Cancer Hospital - Ohio State University
Columbus,  Ohio,  43210-1240
United States
 

Lineberger Comprehensive Cancer Center, UNC
Chapel Hill,  North Carolina,  27599-7295
United States
 

Veterans Affairs Medical Center - White River Junction
White River Junction,  Vermont,  05009
United States
 

Duke Comprehensive Cancer Center
Durham,  North Carolina,  27710
United States
 

Weill Medical College of Cornell University
New York City,  New York,  10021
United States
 

MBCCOP - University of Illinois at Chicago
Chicago,  Illinois,  60612-7323
United States
 

CCOP - Northern Indiana CR Consortium
South Bend,  Indiana,  46601
United States
 

Veterans Affairs Medical Center - Minneapolis
Minneapolis,  Minnesota,  55417
United States
 

University of Minnesota Cancer Center
Minneapolis,  Minnesota,  55455
United States
 

Green Mountain Oncology Group
Bennington,  Vermont,  05201
United States
 

University of Massachusetts Memorial Medical Center - University Campus
Worcester,  Massachusetts,  01655
United States
 

Norris Cotton Cancer Center
Lebanon,  New Hampshire,  03756-0002
United States
 

CCOP - North Shore University Hospital
Manhasset,  New York,  11030
United States
 

Veterans Affairs Medical Center - San Francisco
San Francisco,  California,  94121
United States
 

Western Pennsylvania Hospital
Pittsburgh,  Pennsylvania,  15224
United States
 

University of Chicago Cancer Research Center
Chicago,  Illinois,  60637-1470
United States
 

Lifespan: The Miriam Hospital
Providence,  Rhode Island,  02906
United States
 

Vermont Cancer Center
Burlington,  Vermont,  05401-3498
United States
 

Comprehensive Cancer Center at Wake Forest University
Winston Salem,  North Carolina,  27157-1082
United States
 

UCSF Comprehensive Cancer Center
San Francisco,  California,  94143-0128
United States
 

Cedars-Sinai Medical Center
Los Angeles,  California,  90048
United States
 

State University of New York - Upstate Medical University
Syracuse,  New York,  13210
United States
 

Holden Comprehensive Cancer Center
Iowa City,  Iowa,  52242-1009
United States
 

Lombardi Cancer Center
Washington D.C.,  District of Columbia,  20007
United States
 

Barnes-Jewish Hospital
St. Louis,  Missouri,  63110
United States
 

CCOP - Mount Sinai Medical Center
Miami,  Florida,  33140
United States
 

Veterans Affairs Medical Center - Durham
Durham,  North Carolina,  27705
United States
 

MBCCOP - Massey Cancer Center
Richmond,  Virginia,  23298-0037
United States
 

Memorial Sloan-Kettering Cancer Center
New York City,  New York,  10021
United States
 

Rebecca and John Moores UCSD Cancer Center
La Jolla,  California,  92093-0658
United States
 

Walter Reed Army Medical Center
Washington D.C.,  District of Columbia,  20307-5000
United States
 

Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago,  Illinois,  60612
United States
 

Veterans Affairs Medical Center - Syracuse
Syracuse,  New York,  13210
United States
 

Ellis Fischel Cancer Center - Columbia
Columbia,  Missouri,  65203
United States
 

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse,  New York,  13217
United States
 

Dana-Farber Cancer Institute
Boston,  Massachusetts,  02115
United States
 


Additional Information:
Study ID Numbers:
  CDR0000068995;  CLB-60001
Study Start Date: 
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00026195

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5. R115777 Plus Topotecan in Treating Patients With Advanced Solid Tumors

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