Phase II study of rubitecan, an oral camptothecin in patients with advanced colorectal cancer who have failed previous 5-fluorouracil based chemotherapy.
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.
Patel
Hitendra
H
Division of Hematology/Oncology, Department of Medicine, University of Pittsburgh School of Medicine and Cancer Institute, Pittsburgh, PA 15213, USA.
Stoller
Ronald
R
Auber
Miklos
M
Potter
Douglas
D
Cai
Chao
C
Zamboni
William
W
Kiefer
Gauri
G
Matin
Khalid
K
Schmotzer
Amy
A
Ramanathan
Ramesh K
RK
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
D000970:Antineoplastic Agents; C079905:rubitecan; D005472:Fluorouracil; D002166:Camptothecin