IngentaConnect Phase II trial of edatrexate in relapsed or refractory germ cell ...

Authors: Meyers F.J.¹; Lew D.²; Lara Jr. P.N.¹; Williamson S.³; Marshall E.⁴; Balcerzak S.P.⁵; Rivkin S.E.⁶; Samlowski W.⁷; Crawford E.D.⁸

Source: Investigational New Drugs, Volume 16, Number 4, 1998 , pp. 347-351(5)

Publisher: Springer

Abstract:

Up to 30% of patients with advanced germ cell tumors will fail induction chemotherapy or will relapse. New agents with activity in this still potentially curable subgroup of patients are needed. Edatrexate (10-ethyl, 10-deaza-aminopterin) is a methotrexate analogue that has preclinical and clinical activity in breast, lung, and head and neck cancers, as well as in non-Hodgkin's lymphomas. A phase II trial of edatrexate in relapsed or refractory malignant germ cell tumors was conducted by the Southwest Oncology Group (SWOG). Twenty-five patients were enrolled in the trial. Edatrexate was administered intravenously at a dose of 80 mg/m^2 weekly for four weeks followed by a one-week rest period. The treatment course was repeated every five weeks. Among the 23 patients evaluable for response, there were no objective responses with all patients developing progressive disease. Thirteen patients (56%) developed Grade 3–4 toxicities, predominantly stomatitis and malaise/fatigue/lethargy. One patient developed Grade 4 anemia while another developed grade 4 anemia and thrombocytopenia. No patients discontinued treatment due to toxicity nor were there any toxic deaths. Edatrexate administered in this dose and schedule has no antitumor activity and has substantial toxicity in patients with relapsed or refractory germ cell tumors.

Keywords: germ cell tumors; edatrexate; chemotherapy; salvage

Language: English

Document Type: Regular paper

Affiliations: 1: University of California Davis Cancer Center, Sacramento, CA 2: Southwest Oncology Group Statistical Center, Seattle, WA 3: University of Kansas Medical Center, Kansas City, KS 4: Southeastern Medical Oncology Center, Goldsboro, NC 5: Ohio State University Health Center, Columbus, OH 6: Puget Sound Oncology Consortium, Seattle, WA 7: University of Utah Medical Center, Salt Lake City, UT 8: University of Colorado, Denver, CO, USA

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Phase II trial of edatrexate in relapsed or refractory germ cell tumors: A Southwest Oncology Group study (SWOG 9124)