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Phase II Chemotherapy with AT-125 for Patients with Nonresectable Colorectal Cancer Previously Untreated with Chemotherapy

Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase II Treatment Completed no age specified CAN-NCIC-IND23
NCI-T85-0178W, T85-0178, IND23

Objectives

I.  Evaluate the therapeutic efficacy of AT-125 administered as a 72-hour 
continuous infusion in patients with nonresectable colorectal cancer 
previously untreated with chemotherapy.
II.  Determine the toxicities of AT-125 administered on this schedule.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with a histologic diagnosis 
of advanced colorectal adenocarcinoma not amenable to curative surgery or 
radiotherapy, provided they have received no prior chemotherapy or 
radiotherapy to sites to be assessed for response to protocol treatment.  The 
performance status must be 0-2 and the life expectancy at least 12 weeks.  
Patients must have bidimensionally measurable disease.  Because of potential 
aggravation by AT-125 therapy, patients must not be receiving major 
tranquilizer therapy.  Kidney and bone marrow function must be normal, and 
liver function tests must not exceed 2 times normal values.

Expected Enrollment

36 evaluable patients will be entered, with accrual anticipated to be 
completed within 9-12 months.

Outline

Nonrandomized study.
Single-agent Chemotherapy.  Acivicin, AT-125, NSC-163501.

Published Results

Eisenhauer EA, Maroun JA, Fields AL, et al.: Phase II study of acivicin as a 72-hr continuous infusion in patients with untreated colorectal cancer. A National Cancer Institute of Canada Clinical Trials Group Study. Invest New Drugs 5 (4): 375-8, 1987.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

NCIC-Clinical Trials Group

Jean Maroun, MD, FRCPC, FRCP, Protocol chair
Ph: 613-737-7700 ext. 70185; 888-627-5346
Email: jmaroun@ottawahospital.on.ca

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.