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Phase II-III Study of Chemotherapy with ADR or 5-FU/MeCCNU or 5-FU/Mitomycin C for Advanced Gastric Carcinoma

Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
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 EST-3274
MAYO-706018

Objectives

I.  Compare adriamycin (ADR) chemotherapy vs. combined 5-fluorouracil 
(5-FU)/methyl CCNU (MeCCNU) vs. combined 5-FU/mitomycin C (MITO) in patients 
with advanced gastric cancer.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with measurable disease of 
histologically proven inoperable residual, recurrent or metastatic gastric 
adenocarcinoma.  Patients must be 3 weeks past major surgery, 2 weeks past 
exploration or biopsy and 4 weeks past radiotherapy or chemotherapy, which 
must not have included 5-FU with or without ADR for patients with active heart 
disease.

Expected Enrollment

Protocol closed and terminated 06/77.

Outline

Randomized study.
Randomize patients without heart disease and without prior therapy or with 
prior therapy with other than protocol agents to Arms I, II or III with 
cross-over upon disease progression.  Randomize patients with active heart 
disease and no prior therapy with protocol agents to Arms II or III only, 
without cross-over upon disease progression.  Assign patients with prior 
therapy with protocol agents as indicated.
Arm I:  No heart disease:  Assign patients with prior 5-FU, but no prior ADR.  
Single-agent Chemotherapy.  Adriamycin, ADR, NSC-123127.
Arm II:  No heart disease:  Assign patients with prior nitrosourea, or ADR, 
but no prior 5-FU or MITO.  Active heart disease:  Assign patients with prior 
nitrosourea, but no prior 5-FU or MITO.  2-Drug Combination Chemotherapy.  
5-Fluorouracil, 5-FU, NSC-19893; Mitomycin C, MITO, NSC-26980.
Arm III:  Patients with or without active heart disease:  Assign patients with 
prior MITO, but no prior 5-FU or nitrosourea.  2-Drug Combination 
Chemotherapy.  5-FU; Methyl CCNU, MeCCNU, NSC-95441.

Published Results

Moertel CG, Lavin PT: Phase II-III chemotherapy studies in advanced gastric cancer. Eastern Cooperative Oncology Group. Cancer Treat Rep 63 (11-12): 1863-9, 1979 Nov-Dec.[PUBMED Abstract]

Related Publications

Dewys WD, Begg C, Lavin PT, et al.: Prognostic effect of weight loss prior to chemotherapy in cancer patients. Eastern Cooperative Oncology Group. Am J Med 69 (4): 491-7, 1980.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Paul Carbone, MD, Protocol chair(Contact information may not be current)
Ph: 608-265-8047; 800-622-8922
Email: carbone@biostat.wisc.edu

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.