Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
unspecified adult solid tumor, protocol specific
Brief summary
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.
Detailed description
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.
Interventions
DRUGirinotecan hydrochloride
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | Up to 10 years |
Countries
United States
Outcome results
None listed