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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III, Phase II Treatment Completed no age specified NCI SWOG-7841

Objectives

I.  Determine whether vincristine increases the effectiveness (as determined 
by response rate and survival) of FAM:  5-fluorouracil/mitomycin-C/adriamycin 
in the treatment of advanced, previously untreated gastric adenocarcinoma.  
(FAM-alone treatment arm closed October 1979 and reopened June 1981.)
II.  Determine the efficacy as indicated by response rate and survival of a 
Phase II agent (chlorozotocin, AMSA, and dihydroxyanthracenedione are under 
evaluation as of June 1981) in the treatment of previously untreated gastric 
adenocarcinoma.
III.  Determine by crossover, after relapse or failure on FAM, V-FAM or a 
Phase II agent, the effectiveness, as indicated by response rate and survival, 
of the alternate treatment in advanced gastric adenocarcinoma with prior 
therapy.
IV.  Determine the toxicities of such treatments.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with histologically proven 
advanced gastric adenocarcinoma, Stage IV (measurable disease, Amendment 1, 
October 1979), previously untreated by chemotherapy.  Patients must have 
recovered from toxicity of any prior radiotherapy, which must have terminated 
at least 4 weeks before study entry.  Patients must have a minimum life 
expectancy of 6 weeks, a performance status of 0 to 3, adequate hematologic 
function, serum creatinine within institutional norms and adequate cardiac 
function for Arms I and II.  Per Addendum 1, July 1981, patients with a past 
history of congestive heart failure, ischemic heart disease, or cardiac 
arrhythmias are not eligible; patients whose dose of prior ADR exceeds 400 
mg/sqm will be ineligible for crossover from FAM to DHAD.

Expected Enrollment

35 patients will be entered to Arm III; at least 122 patients will be entered 
to Arms I and II.  Protocol closed August 1982.

Outline

Randomized study.  Randomize patients without measurable disease to Arms I and 
II only.  (All patients must have measurable disease.  Amendment 1, October 
1979.)  Cross over nonresponders in Arms I or II to Arm III, Arm III failures 
to Arm I.
Arm I:  3-Drug Combination Chemotherapy.  FAM:  5-Fluorouracil, 5-FU, 
NSC-19893; Adriamycin, ADR, NSC-123127; Mitomycin-C, MITO, NSC-26980.  (Arm 
closed October 1979, Amendment 1, and reopened June 1981, Amendment 3.)
Arm II:  4-Drug Combination Chemotherapy.  V-FAM:  Vincristine, VCR, 
NSC-67574; 5-FU; ADR; MITO.  (Arm closed June 1981, Amendment 3.) 018090  Arm 
III:  Single-agent Chemotherapy.  Chlorozotocin, CLZ, NSC-178248.  m-AMSA, 
AMSA, NSC-249992, replaced CLZ May 1980; Dihydroxyanthracenedione, DHAD, 
NSC-301739, replaced AMSA June 1981.

Inamasu M, Oishi N, Chen TT, et al.: Phase II study of amsacrine in gastric carcinoma: a Southwest Oncology Group study. Cancer Treat Rep 69(5): 557-558, 1985.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

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