title: A phase I/II study of capecitabine given on a week on/week off schedule combined with bevacizumab and oxaliplatin for patients with untreated advanced colorectal cancer.
abstract: BACKGROUND
  A week on/week off capecitabine schedule with oxaliplatin/bevacizumab was evaluated in patients with metastatic colorectal cancer (mCRC).
  
  
  METHODS
  Forty patients were required. The projected median progression-free survival (PFS) was 12 months (81% power, 1-sided level 0.1 log-rank test). Capecitabine dose was 2500 mg/m(2)/day on days 1-7 (n = 11) and was increased to 3000 mg/m(2)/day (n = 29) in combination with oxaliplatin (85 mg/m(2)) and bevacizumab (5 mg/kg). Cycles were repeated every 2 weeks.
  
  
  RESULTS
  Patient characteristics included Eastern Cooperative Oncology Group (ECOG) performance status 0 (n = 24) or 1 (n = 15); median age of 62 years (range, 38-81 years). Median cycles administered were 7 (range, 125), corresponding to 3.5 months' treatment duration. Pertinent grade 3/4 toxicities seen were diarrhea (18%), hand-foot syndrome (10%), and peripheral neuropathy (10%). Bowel perforation in 1 patient (3%) and 1 death due to a cerebral hemorrhage (3%) were noted. Response rate (RR) was 38% (1 complete and 14 partial responses). Median PFS was 8.6 months (95% confidence interval [CI], 4.7-10.2 months). Median overall survival was 17.2 months (95% CI, 10.4-24.2 months).
  
  
  CONCLUSIONS
  The first US experience of capecitabine to our knowledge (3000 mg/m(2) on days 1-7) in combination with oxaliplatin/bevacizumab in mCRC does not appear to have advantages compared with current standard first-line mCRC treatment regimens.
authors.affiliation: University of Pittsburgh Cancer Institute, Pittsburgh, PA, USA.
authors.forename: Rajesh
authors.initials: R
authors.lastname: Sehgal
authors.forename: Barry C
authors.initials: BC
authors.lastname: Lembersky
authors.forename: Kiran K
authors.initials: KK
authors.lastname: Rajasenan
authors.forename: Theodore L
authors.initials: TL
authors.lastname: Crandall
authors.forename: Edward P
authors.initials: EP
authors.lastname: Balaban
authors.forename: Richard A
authors.initials: RA
authors.lastname: Pinkerton
authors.forename: Patrick
authors.initials: P
authors.lastname: Kane
authors.forename: Amy
authors.initials: A
authors.lastname: Schmotzer
authors.forename: Herbert
authors.initials: H
authors.lastname: Zeh
authors.forename: Douglas M
authors.initials: DM
authors.lastname: Potter
authors.forename: Ramesh K
authors.initials: RK
authors.lastname: Ramanathan
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D000068258:Bevacizumab; D000069287:Capecitabine; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D000077150:Oxaliplatin; D016896:Treatment Outcome
chemical_list: D020533:Angiogenesis Inhibitors; D061067:Antibodies, Monoclonal, Humanized; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000068258:Bevacizumab; D000069287:Capecitabine; D005472:Fluorouracil