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Annals of Oncology 4:254-255, 1993
© 1993 European Society for Medical Oncology

other

A phase II study of weekly Edatrexate (10-EDAM) in metastatic melanoma: A National Cancer Institute of Canada Clinical Trials Group Study

S. Verma1,, I. C. Quirt2, E. A. Eisenhauer3, N. A. Iscoe4, V. J. Young1, A. J. Bodurtha5 and J. Davidson3

1The Ontario Cancer Treatment and Research and Research Foundation (OCTRF), Ottawa Regional Cancer Centre Ottawa;
22The Princess Margaret Hospital Toronto;
3The National Cancer Institute of Canada Clinical Trials Group Kingston
4OCTRF, Toronto-Bayview Cancer Centre Toronto, Ontario
5The Nova Scotia Cancer Treatment and Research Foundation Halifax, Nova Scotia, Canada

Dr Shailendra Verma, OCTRF, Ottawa Regional Cancer Centre, 501 Smyth Road, Ottawa, Ontario, Canada, KIH 8L6

BACKGROUND: Phase I and II clinical trials have demonstrated acceptable toxicity and promising activity of Edatrexate (10-EDAM). The objective of this multicentre phase II study was to determine the efficacy and toxicity of this agent in patients with metastatic melanoma.

PATIENTS AND METHODS: Sixteen previously untreated patients with metastatic melanoma received 10-EDAM, 80 mg/m2/week intravenously. Patients were evaluated for response and toxicity.

RESULTS: There were no objective responses. The median dose intensity of 10-EDAM actually delivered was 56.25 mg/m2/week (70% of projected). Mucositis of any degree was encountered in 93.8% of patients. Grade 3 or 4 mucositis, skin rash, nausea, abdominal pain, neutropenia, thrombocytopenia, anemia and hyperbilirubinemia each were encountered in 1–2 patients. There was 1 toxic death due to 10-EDAM.

CONCLUSION: 10-EDAM is an inactive agent in metastatic melanoma.


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