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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III, Phase II	Treatment	Closed	under 70	NCI	SWOG-8040

Objectives

I.  Determine the response rate and survival in patients with advanced 
pancreatic adenocarcinoma treated with FAM-S:  
5-fluorouracil/adriamycin/mitomycin-C/streptozotocin.
II.  Determine further the toxicity of the FAM-S regimen.
III.  Determine the activity of a Phase II drug in previously untreated 
patients with advanced adenocarcinoma of the pancreas by determination of 
response rate and duration of response and survival.
IV.  Determine further the toxicity of each Phase II agent.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with histologically 
confirmed adenocarcinoma of the exocrine pancreas with distant metastases 
(liver, peritoneum, etc.) or with localized disease not amenable to curative 
surgery or radiotherapy.  There must be objectively measurable disease.  
Patients must be under 70 years of age and have a life expectancy of at least 
10 weeks.  The performance status must be at worst grade 3 by SWOG criteria; 
hematologic and renal function must be adequate.  Patients may not have 
received prior chemotherapy or radiotherapy.  Therapy on this protocol should 
begin not less than 3 weeks after any prior surgery.

Expected Enrollment

25 patients will be treated on the arm described in this master protocol.  
Protocol closed March 1984 with sufficient accrual.

Outline

Randomized study.  This master protocol is designed to facilitate the 
evaluation of many Phase II agents.  Each Phase II agent will be evaluated 
against the combination Chemotherapy described in this summary.  The Phase II 
drug treatments studied will be described in appendices to the master protocol.
Arm I:  4-Drug Combination Chemotherapy.  FAM-S:  5-Fluorouracil, 5-FU, 
NSC-19893; Adriamycin, ADR, NSC-123127; Mitomycin-C, MITO, NSC-26980; 
Streptozotocin, SZC, NSC-85998.
Arm II:  Single-agent Chemotherapy.  Phase II Drug.

Bukowski RM, Fleming TR, Macdonald JS, et al.: Evaluation of combination chemotherapy and phase II agents in pancreatic adenocarcinoma. A Southwest Oncology Group study. Cancer 71 (2): 322-5, 1993.[PUBMED Abstract]

Bukowski RM, Inamasu M, Taylor S, et al.: Randomized trial of combination chemotherapy vs. a phase II drug in metastatic adenocarcinoma of the pancreas: Southwest Oncology Group study. [Abstract] Proceedings of the American Society of Clinical Oncology 4: C-311, 80, 1985.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Ronald Bukowski, MD, Protocol chair		Ph: 216-444-6825; 800-862-7798