Phase II trial of edatrexate in patients with advanced pancreatic adenocarcinoma.
BACKGROUND
The methotrexate analogue 10-ethyl-10-deazaaminopterin (10-EdAM, or edatrexate) has shown antitumor activity in preclinical testing and clinical studies of patients with breast, lung and head and neck carcinomas. A phase II study was conducted in patients with advanced pancreatic adenocarcinoma.


METHODS
Forty patients were enrolled on the clinical trial. Edatrexate was administered intravenously at a dose of 80 mg/m2 weekly for 5 weeks. The treatment course was repeated every 6 weeks.


RESULTS
Two partial responses were observed. Both of these patients had partial responses which lasted 2 and 3.5 months. The median survival for all patients was 3.5 months. Serious (grade 3 or 4) toxic effects were primarily mucosal, hematologic, and dermatologic. Two patients experienced severe pulmonary toxic reactions.


CONCLUSIONS
At the dose and schedule used, edatrexate was poorly tolerated and did not demonstrate significant antitumor activity.
Moore
D F
DF
Division of Medicine, University of Texas M. D. Anderson Cancer Center, Houston.
Pazdur
R
R
Abbruzzese
J L
JL
Ajani
J A
JA
Dubovsky
D W
DW
Wade
J L
JL
Belt
R J
RJ
Mangold
C
C
Bready
B
B
Winn
R J
RJ
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000630:Aminopterin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000556:secondary; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy*; D015996:Survival Rate
D000970:Antineoplastic Agents; C040210:edatrexate; D000630:Aminopterin