title: Phase II study of rubitecan, an oral camptothecin in patients with advanced colorectal cancer who have failed previous 5-fluorouracil based chemotherapy.
abstract: BACKGROUND
  Rubitecan (RFS-2000, 9NC, Orathecin) is an orally bioavailable camptothecin analogue, with evidence of preclinical activity in colon cancer cell lines. We evaluated oral rubitecan (5 days on, 2 days rest per week) on a continuous schedule, in patients with advanced colorectal cancer (CRC), who progressed after 5-fluorouracil based chemotherapy.
  
  
  RESULTS
  Fourteen eligible patients were treated with rubitecan at 1.5 mg/m2/day on a 5 day/week continuous schedule. Therapy was well tolerated with most adverse events in the mild to moderate category. Grade 3/4 toxicity consisting of anemia, diarrhea and elevated bilirubin was seen in 4 patients. No responses were seen in 13 evaluable patients. Overall median survival (95% confidence interval) was 10.1 (range 3.1-12.6) months, and median time to progression was 2.1 months.
  
  
  CONCLUSIONS
  Administration of rubitecan was well tolerated, but this schedule does not appear to have clinical activity in patients with advanced previously treated CRC.
authors.affiliation: Division of Hematology/Oncology, Department of Medicine, University of Pittsburgh School of Medicine and Cancer Institute, Pittsburgh, PA 15213, USA.
authors.forename: Hitendra
authors.initials: H
authors.lastname: Patel
authors.forename: Ronald
authors.initials: R
authors.lastname: Stoller
authors.forename: Miklos
authors.initials: M
authors.lastname: Auber
authors.forename: Douglas
authors.initials: D
authors.lastname: Potter
authors.forename: Chao
authors.initials: C
authors.lastname: Cai
authors.forename: William
authors.initials: W
authors.lastname: Zamboni
authors.forename: Gauri
authors.initials: G
authors.lastname: Kiefer
authors.forename: Khalid
authors.initials: K
authors.lastname: Matin
authors.forename: Amy
authors.initials: A
authors.lastname: Schmotzer
authors.forename: Ramesh K
authors.initials: RK
authors.lastname: Ramanathan
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D019008:Drug Resistance, Neoplasm; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016019:Survival Analysis; D017211:Treatment Failure; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; C079905:rubitecan; D005472:Fluorouracil; D002166:Camptothecin