Tocladesine in Treating Patients With Recurrent or Progressive Metastatic Colorectal Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jonsson Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: 8-chloro-cyclic adenosine monophosphate

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