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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III, Phase II Treatment Completed no age specified NCI SWOG-8223/24/25 SWOG-8224, SWOG-8225

Objectives

I.  Estimate and compare response rates produced by two combination regimens 
(methotrexate/5-fluorouracil vs. cis-platinum/5-fluorouracil) in patients with 
head and neck cancer.
II.  Estimate and compare response rates in patients who receive either of the 
two combination regimens at initial randomization vs. those who receive 
therapy after failure on the protocol's Phase II agent (bisantrene).
III.  Characterize toxicity experience and survival on 
methotrexate/5-fluorouracil, on cis-platinum/5-fluorouracil, and for each 
Phase II agent by type, severity, and frequency.
IV.  Provide a Master Protocol design that permits the planned substitution of 
either (or both) combination arms as well as the sequential use of available 
Phase II agents.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with histologically proven 
advanced squamous cell carcinoma of the head and neck region that is not 
curable by other forms of therapy.  There must be objectively measurable 
lesions and no ascites or pleural effusions.  Patients must have a life 
expectancy of at least 8 weeks, a performance status of at most 2, and 
adequate hematologic, renal, and hepatic function.  Patients must not have 
received prior chemotherapy for recurrent disease; prior adjuvant chemotherapy 
is allowed provided that at least 6 months have elapsed since the last 
chemotherapy administration.  Concomitant radiotherapy, hormonal therapy, or 
other chemotherapy is not allowed.  Patients with a cumulative dose of prior 
adriamycin exceeding 400 mg/sqm are not eligible; those with a prior dose of 
350 mg/sqm must receive cardiac monitoring.  There must be no history of 
congestive heart failure, ischemic heart disease, cardiac arrhythmias or 
indications of unstable cardiac status (unstable cardiac rhythm or recent 
development of cardiac decompensation).

Expected Enrollment

Approximately 318 (106 per arm) evaluable patients will be required.  Each 
Phase II agent will be evaluated in 19 patients; if no responses are observed, 
subsequent patients receive the next Phase II agent; if responses are 
observed, a total of 25 patients will be treated.  If a total of 106 patients 
enter Arm III, four or five Phase II agents can be studied.  Protocol closed 
January 1983 as a result of discontinuation of the Head and Neck Committee.

Outline

Randomized study.  Patients are initially registered on SWOG-8223 and 
randomized to Arms I, II, and III.  Patients who fail or relapse on Arm III 
are re-registered on SWOG-8224 and re-randomized to Arms I and II.  This 
Master Protocol is designed to permit the substitution of either (or both) 
combination regimens as well as the sequential use of Phase II agents.
Arm I:  2-Drug Combination Chemotherapy.  5-Fluorouracil, 5-FU, NSC-19893; 
Methotrexate, MTX, NSC-740; with Citrovorum Factor, CF, NSC-3590.
Arm II:  2-Drug Combination Chemotherapy.  5-FU; cis-Platinum, CACP, 
NSC-119875.
Arm III:  Phase II Agent Chemotherapy.  Bisantrene, 
Anthracenedicarboxaldehyde, ADC, NSC-337766.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Charles Coltman, MD, Protocol chair(Contact information may not be current)		Ph: 210-567-2710