SWOG clinical trial number
S9700

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

Closed
Phase
Accrual
90%
Published
Abbreviated Title
PANCREAS
Activated
09/15/1997
Closed
06/19/2001
Participants

Research committees

Gastrointestinal Cancer

Treatment

5-Fluorouracil Dipyridamole Leucovorin Calcium Mitomycin-C

Eligibility Criteria Expand/Collapse

Stage II/III (based on AJCC Staging, Version 4) pancreatic adenocarcinoma not amenable to curative resection; PS 0-2; Meas or Eval disease; Histologically or cytologically proven ductal or undifferentiated adenocarcinoma (see protocol for acceptable histological types); No prior systemic CT/RT for pancreatic canc; No other prior malig except adeq treated basal cell or squamous cell skin canc, in situ cervical canc, adeq treated Stage I/II canc from which pt is currently in complete remission, or any other canc from which pt has been dz free for 5 yrs; >= 2 wks beyond any surgical bypass procedure & recovered from all surgical effects. A pancreatic primary canc must be estab by surgical exploration, CT scan or MRI. Pts who have unresec but localized dz are elig (determined by total occlusion or encasement > 75% of main portal vein or superior mesenteric vein, total occlusion of or > 75% circumferential encasement of superior mesenteric artery, celiac axis or common hepatic artery, right or left hepatic arteries, total occlusion of peripheral splenic vein in pts w/o evidence of cirrhosis, tumor size of >= 5 cm involving body or tail of pancreas, or enlargement of celiac axis nodes w/ subsequent biopsy to prove pathologic involvement); Pts must not have lost >15% of actual body wt. (must have an oral intake of greater than 1,200 calories/day at time of regis); Preg/nursing women are ineligible.

Publication Information Expand/Collapse

2007

Phase II trial of infusional 5-fluorouracil, leucovorin, mitomycin-c and dipyridamole in locally advanced unresectable pancreatic adenocarcinoma: SWOG S9700 [PMID 17470859]

WH Isacoff;JK Benedetti;JL Barstis;AR Jazieh;JS Macdonald;PA Philip Journal of Clinical Oncology 25(13):1665-1669

2002

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

WH Isacoff;J Benedetti;JS Macdonald;JL Abbruzzese Proc of the American Society of Clinical Oncology 21:137a(#544)