|
|||||
|
|
A phase II study of weekly Edatrexate (10-EDAM) in metastatic melanoma: A National Cancer Institute of Canada Clinical Trials Group Study |
|
| Authors: | Verma, S. Quirt, I. C. Eisenhauer, E. A. Iscoe, N. A. Young, V. J. Bodurtha, A. J. Davidson, J. |
| Affiliation: | 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 |
| Abstract: | BACKGROUND: Phase I and II clinical trials have demonstrated acceptabletoxicity and promising activity of Edatrexate (10-EDAM). Theobjective of this multicentre phase II study was to determinethe efficacy and toxicity of this agent in patients with metastaticmelanoma. PATIENTS AND METHODS: Sixteen previously untreated patients with metastatic melanomareceived 10-EDAM, 80 mg/m2/week intravenously. Patients wereevaluated for response and toxicity. RESULTS: There were no objective responses. The median dose intensityof 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 encounteredin 12 patients. There was 1 toxic death due to 10-EDAM. CONCLUSION: 10-EDAM is an inactive agent in metastatic melanoma. |
| Keywords: | |
| 本文献已被 Oxford 等数据库收录！ | |