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Annals of Oncology 5:286-287, 1994
© 1994 European Society for Medical Oncology

other

Phase II trial of edatrexate in patients with advanced pancreatic adenocarcinoma

D. F. Moore, Jr1, R. Pazdur1,, J. L. Abbruzzese1, J. A. Ajani1, D. W. Dubovsky2, J. L. Wade, III3, R. J. Belt4, C. Mangold1, B. Bready5 and R. J. Winn1

1Division of Medicine, The University of Texas M. D. Anderson Cancer Center Houston, TX
2Atlanta Regional Community Clinical Oncology Program Atlanta, GA
3Central Illinois Community Clinical Oncology Program Springfield, IL
4Kansas City Community Clinical Oncology Program Kansas City, MO
5Division of Pharmacy, The University of Texas M. D. Anderson Cancer Center Houston, TX, U.S.A.

Correspondence to: Richard Pazdur, MD, Division of Medicine, Box 92, The University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Boulevard, Houston TX 77030, USA.

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.

PATIENTS AND 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.

CONCLUSION: At the dose and schedule used, edatrexate was poorly tolerated and did not demonstrate significant antitumor activity.

10-EdAM, antimetabolite, edatrexate, folate antagonist, methotrexate, pancreatic adenocarcinoma


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