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Phase II Study of Fluorouracil, Leucovorin, Mitomycin and Dipyridamole in Patients with Locally Advanced Unresected Pancreatic Adenocarcinoma

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

Alternate Title

Combination Chemotherapy in Treating Patients With Stage II or Stage III Pancreatic Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase II Treatment Completed Not specified NCI SWOG-S9700
NCT00003018, S9700

Objectives

I. Assess the one year overall survival rate of patients with advanced, 
unresectable pancreatic cancer treated with fluorouracil, leucovorin, 
mitomycin and dipyridamole.

II. Assess the response rate in this group of patients.

III. Evaluate the frequency and severity of the toxic effects associated with 
this therapy.

IV. Assess the rate of resectability in patients who respond to therapy.

Entry Criteria

Disease Characteristics:


Histologically or cytologically proven stage II or III pancreatic
adenocarcinoma 
 Ductal adenocarcinoma
 Mucinous noncystic carcinoma
 Signet ring cell carcinoma
 Adenosquamous carcinoma
 Undifferentiated (anaplastic) carcinoma
 Mixed ductal-endocrine carcinoma
 Well differentiated adenocarcinoma
 Moderately well or poorly differentiated adenocarcinoma
 Undifferentiated ductal carcinoma

Must have unresectable and localized disease

Measurable or evaluable disease

Prior/Concurrent Therapy:


Biologic therapy:
 Not specified   

Chemotherapy:
 No prior systemic chemotherapy for pancreatic cancer

Endocrine therapy:
 Not specified

Radiotherapy:
 No prior radiation therapy for pancreatic cancer

Surgery:
 At least 2 weeks since prior surgical bypass procedure and recovered

Patient Characteristics:


Age:
 Not specified

Performance status:
 SWOG 0-2

Life expectancy:
 Not specified

Hematopoietic:
 Not specified

Hepatic:
 Not specified

Renal:
 Not specified   

Other:
 Not pregnant or nursing
 Fertile patients must use effective contraception 
 Loss of no greater than 15% of actual body weight
 Oral intake of greater than 1,200 calories per day
 No other malignancy within the past 5 years except adequately treated basal
  or squamous cell skin cancer, carcinoma in situ of the cervix, or any stage
  I or II cancer that is currently in complete remission

Expected Enrollment

A total of 55 patients will be accrued for this study.

Outline

All patients undergo surgical placement of an indwelling central venous line.

Patients receive fluorouracil IV by continuous infusion on days 1-28, 
leucovorin calcium IV on days 1, 8, 15, and 22, oral dipyridamole on days 
1-28, and mitomycin IV every 6 weeks starting on day 1.  Treatment repeats 
every 6 weeks for 4 courses.

Patients with a partial or complete response are reevaluated for possible 
surgical resection.  Resected patients resume chemotherapy 4-8 weeks after 
surgery for an additional 16 weeks.

Patients are followed every 6 months for 2 years, then annually until death.

Published Results

Isacoff WH, Bendetti JK, Barstis JJ, et al.: Phase II trial of infusional fluorouracil, leucovorin, mitomycin, and dipyridamole in locally advanced unresectable pancreatic adenocarcinoma: SWOG S9700. J Clin Oncol 25 (13): 1665-9, 2007.[PUBMED Abstract]

Isacoff WH, Benedetti J, MacDonald JS, et al.: Continuous infusion (CI) 5 fluorouracil (5FU), leucovorin (LV), mitomycin C (Mito C) and dipyridamole (D) in patients with locally advanced unresectable pancreatic adenocarcinoma - a phase II trial of the Southwest Oncology Group. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-544, 2002.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

William Isacoff, MD, Protocol chair
Ph: 310-824-4133; 888-798-0719
Email: isacoff@earthlink.net

Registry Information

Official Title		A Phase II Trial of Infusional 5-Fluorouracil (5-FU), Calcium Leucovorin (LV), Mitomycin-C (Mito-C), and Dipyridamole (D) in Patients with Locally Advanced Unresected Pancreatic Adenocarcinoma

Trial Start Date		1997-09-15

Registered in ClinicalTrials.gov		NCT00003018

Date Submitted to PDQ		1997-05-29

Information Last Verified		2007-05-02

NCI Grant/Contract Number		CA32102

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.