title: SarCNU in recurrent or metastatic colorectal cancer: a phase II study of the National Cancer Institute of Canada Clinical Trials Group.
abstract: OBJECTIVE
  To evaluate the activity and toxicity of SarCNU, an oral chloroethylnitrosourea in patients with recurrent or metastatic colorectal cancer who have progressed after first-line chemotherapy.
  
  
  METHODS
  Eighteen patients with recurrent or metastatic colorectal cancer following first-line chemotherapy were treated with SarCNU 860 mg/m2 orally day 1, 5 and 9 every 6 weeks. The patient's median age was 64 and the ECOG performance status was 0 in six, 1 in eleven and 2 in one patients. All patients were evaluable for toxicity and 16 were evaluable for response.
  
  
  RESULTS
  There were no objective responses (0%). One patient had stable disease and 15 had progressive disease at their first follow-up assessment. Median survival was 7.36 months (3.75-7.49 95% C.I.). Neutropenia and thrombocytopenia were the most severe toxicities (grade 3-4 in six and nine patients respectively). Pulmonary toxicity was also seen in five patients who had a drop of DLCO grade from baseline and two patients who had a fall in FVC from baseline.
  
  
  CONCLUSIONS
  SarCNU is inactive in recurrent or metastatic colorectal patients who have progressed after first-line chemotherapy.
authors.affiliation: Cancer Care Manitoba, St. Boniface General Hospital, 409, Winnipeg, Manitoba, Canada. ralph.wong@cancercare.mb.ca
authors.forename: R P
authors.initials: RP
authors.lastname: Wong
authors.forename: T
authors.initials: T
authors.lastname: Baetz
authors.forename: M J
authors.initials: MJ
authors.lastname: Krahn
authors.forename: J
authors.initials: J
authors.lastname: Biagi
authors.forename: N
authors.initials: N
authors.lastname: Wainman
authors.forename: E
authors.initials: E
authors.lastname: Eisenhauer
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002170:Canada; D002330:Carmustine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology* / Q000517:prevention & control; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis / Q000188:drug therapy; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D015996:Survival Rate
chemical_list: D000970:Antineoplastic Agents; C044565:2-((((2-chloroethyl)nitrosoamino)carbonyl)amino)propanamide; D002330:Carmustine