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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed over 18 NCI OSU-84HO272 OSU-8507, NCI-T85-0008D, T85-0008

Objectives

I.  Determine the antitumor activity of 5,6-dihydro-5-azacytidine (DHAC) in 
patients with metastatic adenocarcinoma of the colon who have not previously 
received chemotherapy or immunotherapy.
II.  Determine the acute and chronic side effects of DHAC, particularly with 
regard to serositis.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients over the age of 18 years 
with measurable or evaluable, histologically confirmed metastatic 
adenocarcinoma of the colon.  One prior chemotherapy or immunotherapy regimen 
is allowed.  The life expectancy must be at least 12 weeks and the functional 
capacity (Zubrod) 2 or better.  Liver, kidney, and bone marrow function must 
be adequate.  Concurrent hormonal or cytotoxic therapy is not allowed; 
palliative radiotherapy may be allowed after discussion with the principal 
investigator, but not to an indicator lesion.

Expected Enrollment

If there is at least one response among the first 14 patients, a total of 25 
will be enrolled; otherwise, accrual will cease at 14.

Outline

Nonrandomized study.
Single-agent Chemotherapy.  5,6-Dihydro-5-azacytidine, DHAC, NSC-264880.

Trial Contact Information

Trial Lead Organizations

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Brent Behrens, MD, PhD, Protocol chair		Ph: 614-442-3130