Expired Study
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Los Angeles, California 90095


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00021268


Primary Contact:

Study Chair
Lee S. Rosen, MD
Jonsson Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90095
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 25, 2017

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