title: Evaluation of combination chemotherapy and phase II agents in pancreatic adenocarcinoma. A Southwest Oncology Group study.
abstract: BACKGROUND
  Pancreatic carcinoma responds poorly to conventional chemotherapy. To identify potentially useful agents, a sequence of clinical trials were done.
  
  
  METHODS
  A series of Phase II randomized trials were done by the Southwest Oncology Group in which patients with metastatic or advanced pancreatic cancer were randomized to receive single agents (methylglyoxal-bis-guanylhydrazone [MGBG], dihydroxyanthracenedione [DHAD], and aziridinylbenzoquinone [AZQ]) or a combined regimen of 5-fluorouracil, doxorubicin, mitomycin C, and streptozotocin (FAM-S). Toxicity, response, and survival were determined.
  
  
  RESULTS
  Seventy-one patients received FAM-S and 82, the Phase II single agents. Response rates (95% confidence intervals) for the various treatments were: FAM-S, 11% (0%, 21%); MGBG, 6% (0.8%, 21%); DHAD, 0% (0%, 12%); and AZQ, 0% (0%, 16%). The median survival times were: FAM-S Group, 4.8 months and Phase II agent Group, 3.4 months.
  
  
  CONCLUSIONS
  The FAM-S regimen and the Phase II agents tested did not have substantial antitumor activity in pancreatic cancer. The use of new agents as initial therapy is reasonable.
authors.affiliation: Cleveland Clinic Foundation, Ohio.
authors.forename: R M
authors.initials: RM
authors.lastname: Bukowski
authors.forename: T R
authors.initials: TR
authors.lastname: Fleming
authors.forename: J S
authors.initials: JS
authors.lastname: Macdonald
authors.forename: N
authors.initials: N
authors.lastname: Oishi
authors.forename: S A
authors.initials: SA
authors.lastname: Taylor
authors.forename: L H
authors.initials: LH
authors.lastname: Baker
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D004317:Doxorubicin / Q000008:administration & dosage; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage; D010190:Pancreatic Neoplasms / Q000188:drug therapy*; D013311:Streptozocin / Q000008:administration & dosage
chemical_list: D016685:Mitomycin; D013311:Streptozocin; D004317:Doxorubicin; D005472:Fluorouracil