Colon Cancer Clinical Trial
Tocladesine in Treating Patients With Recurrent or Progressive Metastatic Colorectal Cancer
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.
Full 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.
Eligibility 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
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There is 1 Location for this study
Los Angeles California, 90095, United States
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