Tocladesine in Treating Patients With Recurrent or Progressive Metastatic Colorectal Cancer

Jonsson Comprehensive Cancer Center

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Colorectal Cancer

Interventions

tocladesineDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, United States

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.