Colorectal Cancer
Conditions
Keywords
stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of tocladesine in treating patients who have recurrent or progressive metastatic colorectal cancer.
Detailed description
OBJECTIVES: * Determine the maximum tolerated dose of tocladesine in patients with recurrent or progressive metastatic colorectal cancer. * Determine the qualitative and quantitative toxicity of this drug in these patients. * Assess any therapeutic activity in patients treated with this drug. OUTLINE: This is a dose-escalation, multicenter study. Patients receive tocladesine IV continuously on days 1-5 and 8-12. Treatment repeats every 21 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of tocladesine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, up to 14 additional patients are treated at this dose level. PROJECTED ACCRUAL: A total of 3-38 patients will be accrued for this study.
Interventions
DRUGtocladesine
Sponsors
National Cancer Institute (NCI)
Jonsson Comprehensive Cancer Center
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Diagnosis of metastatic carcinoma of the colon or rectum * Recurrent or progressive after failing prior fluorouracil and irinotecan chemotherapy, sequentially or in combination, unless unable to tolerate irinotecan * Measurable disease PATIENT CHARACTERISTICS: Age: * 18 to 75 Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST and ALT no greater than 5 times ULN * PT/aPTT no greater than 1.2 times ULN Renal: * Creatinine no greater than 1.5 mg/dL * Creatinine clearance at least 50 mL/min * No impaired renal function Cardiovascular: * No impaired cardiac function Other: * No active infection * No other malignancy within the past 5 years except basal cell or squamous cell skin cancer * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * At least 4 weeks since prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since prior radiotherapy Surgery: * Not specified Other: * No other concurrent anticancer drugs * No concurrent chronic non-steroidal anti-inflammatory agents * No concurrent chronic therapeutic anticoagulation
Countries
United States
Outcome results
None listed