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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Supportive care, Treatment Completed no age specified DFCI-75112

Objectives

I.  Determine whether the gastrointestinal toxicity of 5-FU is reduced, and 
whether therapeutic efficacy is increased, by concurrent administration or 
sequential administration of oral nonabsorbable antibiotics, vancomycin and 
tobramycin.
II.  Determine whether bowel flora are suppressed in a small group of 
ambulatory patients with metastatic colorectal carcinoma who are receiving 
standard doses of 5-FU with oral nonabsorbable antibiotics.
III.  Determine the objective response rate in patients with colorectal 
carcinoma who are receiving 5-FU and nonabsorbable antibiotics.
IV.  Determine whether 5-FU alters gastrointestinal permeability and if this 
side effect is reduced or prevented by antibiotics.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with measurable metastatic 
adenocarcinoma of the colorectum with a performance status greater than 
bed-to-chair existence greater than 50% of waking hours.

Expected Enrollment

Protocol closed 08/77 and terminated 09/77.

Outline

Randomized study.
Arm I:  Single-agent Chemotherapy followed by oral antibiotics.  
5-Fluorouracil, 5-FU, NSC-19893; tobramycin, vancomycin with cross-over to Arm 
II.
Arm II:  Single-agent Chemotherapy with concurrent oral antibiotics.  5-FU and 
tobramycin and vancomycin with cross-over to Arm I.

Trial Contact Information

Trial Lead Organizations

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Emil Frei, MD, Protocol chair(Contact information may not be current)		Ph: 617-632-3474; 866-790-4500