title: A phase II study of weekly edatrexate (10-EDAM) in metastatic melanoma. A National Cancer Institute of Canada Clinical Trials Group study.
abstract: 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.
  
  
  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.
  
  
  CONCLUSIONS
  10-EDAM is an inactive agent in metastatic melanoma.
authors: Ontario Cancer Treatment and Research and Research Foundation (OCTRF), Ottawa Regional Cancer Centre, Canada.
authors: S
authors: S
authors: Verma
authors: I C
authors: IC
authors: Quirt
authors: E A
authors: EA
authors: Eisenhauer
authors: N A
authors: NA
authors: Iscoe
authors: V J
authors: VJ
authors: Young
authors: A J
authors: AJ
authors: Bodurtha
authors: J
authors: J
authors: Davidson
mesh_terms: D000328:Adult; D000368:Aged; D000630:Aminopterin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D002170:Canada; D004334:Drug Administration Schedule; D006801:Humans; D008545:Melanoma / Q000188:drug therapy* / Q000556:secondary; D008875:Middle Aged
chemical_list: D000970:Antineoplastic Agents; C040210:edatrexate; D000630:Aminopterin