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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Closed	no age specified		MDA-DM-8204

Objectives

I.  Evaluate whether pretreatment with anguidine can induce preferential 
cytostasis in normal host tissue and thereby permit administration of higher 
doses of 5-fluorouracil and mitomycin-C in patients with gastrointestinal 
malignancies.
II.  Determine incidence and duration of response and survival following 
front-line treatment with anguidine and 5-fluorouracil or mitomycin-C in 
patients with colorectal cancer and salvage therapy with the same agents in 
patients with gastric cancer.
III.  Determine the associated acute and chronic toxicities of this program, 
particularly modification of the well-known toxicities of 5-fluorouracil and 
mitomycin-C, after pretreatment with anguidine.
IV.  Combine all three agents once the beneficial effects of anguidine 
pretreatment for both 5-fluorouracil and mitomycin-C administered singly have 
been established.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with biopsy-proven, 
unresectable colorectal carcinoma.  Patients with refractory gastric carcinoma 
are eligible for salvage therapy.  Measurable disease is preferred, but 
evaluable disease is acceptable.  Patients must have a life expectancy of at 
least 3 months and adequate bone marrow (granulocytes greater than 
1,500/microliter and platelets greater than 100,000/microliter) and renal 
(creatinine at most 2.0 mg/dl) function.  Prior 5-fluorouracil or mitomycin-C 
is allowed, provided that (1) treatment was given as adjuvant chemotherapy by 
intravenous or hepatic arterial infusion with a treatment-free interval of at 
least 2 years; or (2) treatment was given by hepatic arterial infusion for 
initially localized metastatic disease; or (3) at most two courses of 
5-fluorouracil or mitomycin-C were given for metastatic disease without 
disease progression.

Expected Enrollment

A minimum of 28 evaluable patients (14 per arm) will be required.  Protocol 
closed to patient entry in April 1983.

Outline

Randomized study.
Arm I:  2-Drug Combination Chemotherapy.  Anguidine, ANG, NSC-141537; 
5-Fluorouracil, 5-FU, NSC-19893.
Arm II:  2-Drug Combination Chemotherapy.  ANG; Mitomycin-C, MITO, NSC-26980.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Eugene M. McKelvey, MD, Protocol chair		Ph: 713-792-2570; 800-392-1611