title: Capecitabine, irinotecan, oxaliplatin (CAPIRINOX) and concomitant irradiation in advanced rectal cancer: the Lyon R-02-01 phase I trial.
abstract: OBJECTIVE
  To determine the feasibility of radiotherapy-associated capecitabine, irinotecan and oxaliplatin administration at five dose levels for the treatment of locally advanced rectal cancer, with or without metastasis.
  
  
  METHODS
  This was a bicentric phase I trial, including patients with locally advanced rectal cancer, with or without metastasis. Chemotherapy comprised capecitabine (1100, 1300 or 1500 mg/m2/day, every day), irinotecan (30, 40 or 50mg/m2, once per week for 6 weeks) with the addition of oxaliplatin (40 mg/m2 at level 4 or 50 mg/m2 at level 5, once per week for 6 weeks). Radiotherapy at 46 Gy plus a boost of 4 Gy was administered concomitantly.
  
  
  RESULTS
  Twelve patients received four levels of dose. As a supplement to radiotherapy, the combination of capecitabine and irinotecan at the respective doses of 1500 mg/m2/day and 50 mg/m2/week was feasible and well tolerated. The addition of oxaliplatin to this combination provoked toxicity (grade 3/4 vomiting, diarrhoea) for two-thirds of the patients.
  
  
  CONCLUSIONS
  A treatment associating radiotherapy (46 Gy+4 Gy) with concomitant chemotherapy comprising capecitabine (1500 mg/m2/day, every day) and irinotecan (50 mg/m2/week, for 5 weeks) was feasible and well tolerated. The addition of oxaliplatin to these doses was prohibitory to the continuation of treatment due to unacceptable toxicity.
authors.affiliation: Centre Hospitalier Lyon sud, France. pierreheudel@caramail.com <pierreheudel@caramail.com>
authors.forename: P
authors.initials: P
authors.lastname: Heudel
authors.forename: P
authors.initials: P
authors.lastname: Romestaing
authors.forename: N
authors.initials: N
authors.lastname: Barbet
authors.forename: C
authors.initials: C
authors.lastname: Falandry
authors.forename: B
authors.initials: B
authors.lastname: You
authors.forename: O
authors.initials: O
authors.lastname: Glehen
authors.forename: G
authors.initials: G
authors.lastname: Freyer
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D000069287:Capecitabine; D003131:Combined Modality Therapy; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D004305:Dose-Response Relationship, Drug; D005240:Feasibility Studies; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D000077150:Oxaliplatin; D020266:Radiotherapy, Conformal; D012004:Rectal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000069287:Capecitabine; D000077146:Irinotecan; D005472:Fluorouracil; D002166:Camptothecin