title: Phase II studies of Elsamitrucin in breast cancer, colorectal cancer, non-small cell lung cancer and ovarian cancer. EORTC Early Clinical Trials Group.
abstract: OBJECTIVE
  To test the antitumor activity of Elsamitrucin in metastatic cancer of the breast, colon and rectum, non-small cell lung and ovary.
  
  
  METHODS
  Eligibility required histologically proven cancer. Patients with colorectal or non-small cell lung cancer could not have received prior chemotherapy. Patients were entered if WHO PS was < or = 2 and organ functions were normal. Treatment consisted of Elsamitrucin 25 mg/m2/week given as a 5-10 min infusion for at least 3-6 weekly doses.
  
  
  RESULTS
  One hundred and five patients entered the studies, 97 were eligible, 94 are evaluable for toxicity and 75 for response. Toxicity mainly consisted of mild nausea/vomiting, and less frequently reversible hepatotoxicity and malaise. No objective responses were seen.
  
  
  CONCLUSIONS
  Elsamitrucin at this dose and schedule is not an active drug in metastatic breast cancer, colorectal cancer, non-small cell lung cancer or ovarian cancer.
authors.affiliation: Rotterdam Cancer Institute, The Netherlands.
authors.forename: J
authors.initials: J
authors.lastname: Verweij
authors.forename: J
authors.initials: J
authors.lastname: Wanders
authors.forename: A L
authors.initials: AL
authors.lastname: Nielsen
authors.forename: N
authors.initials: N
authors.lastname: Pavlidis
authors.forename: F
authors.initials: F
authors.lastname: Calabresi
authors.forename: W
authors.initials: W
authors.lastname: ten Bokkel Huinink
authors.forename: U
authors.initials: U
authors.lastname: Bruntsch
authors.forename: M
authors.initials: M
authors.lastname: Piccart
authors.forename: H
authors.initials: H
authors.lastname: Franklin
authors.forename: S B
authors.initials: SB
authors.lastname: Kaye
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000617:Aminoglycosides; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000903:Antibiotics, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy; D015179:Colorectal Neoplasms / Q000188:drug therapy; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy*; D010051:Ovarian Neoplasms / Q000188:drug therapy
chemical_list: D000617:Aminoglycosides; D000900:Anti-Bacterial Agents; D000903:Antibiotics, Antineoplastic; C049904:elsamicin A