title: CPT-11 for bile-duct and gallbladder carcinoma: a phase II North Central Cancer Treatment Group (NCCTG) study.
abstract: BACKGROUND
  Bile-duct and gallbladder carcinomas are rare cancers. Once they have spread beyond the point of surgical resectability, no therapies have shown meaningful long-term benefit. These cancers are typically refractory to standard chemotherapy agents. Based on preclinical work showing activity of CPT-11, we performed a phase II trial to assess its activity in patients with bile-duct or gallbladder carcinomas.
  
  
  METHODS
  Patients with histologic or cytologic evidence of locally advanced or metastatic bile-duct or gallbladder carcinoma were potentially eligible for this study. Patients meeting study eligibility and who signed an informed consent were given CPT-11 125 mg/m2 weekly for 4 wk followed by a 2-wk break from therapy. The starting dose of CPT-11 was later reduced to 100 mg/m2 grade IV toxicity. Patients continued on treatment if they showed evidence of benefit and tolerated therapy.
  
  
  RESULTS
  A total of 39 patients were enrolled, and 36 were evaluable. The overall confirmed response rate was 8%. One CR and two PRs were seen. A high frequency of toxicity was seen. However, no unusual or unexpected toxicities occurred.
  
  
  CONCLUSIONS
  CPT-11 is ineffective therapy for patients with locally advanced or metastatic bile-duct or gallbladder carcinoma.
authors.affiliation: Mayo Clinic and Mayo Foundation, Rochester, MN, USA. alberts.steven@mayo.edu
authors.forename: Steven R
authors.initials: SR
authors.lastname: Alberts
authors.forename: Paul A
authors.initials: PA
authors.lastname: Fishkin
authors.forename: Lawrence J
authors.initials: LJ
authors.lastname: Burgart
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Cera
authors.forename: Michelle R
authors.initials: MR
authors.lastname: Mahoney
authors.forename: Roscoe F
authors.initials: RF
authors.lastname: Morton
authors.forename: Patricia A
authors.initials: PA
authors.lastname: Johnson
authors.forename: Suresh
authors.initials: S
authors.lastname: Nair
authors.forename: Richard M
authors.initials: RM
authors.lastname: Goldberg
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D001650:Bile Duct Neoplasms / Q000188:drug therapy* / Q000473:pathology; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology*; D002277:Carcinoma / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D005706:Gallbladder Neoplasms / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D007262:Infusions, Intravenous; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D000077146:Irinotecan; D002166:Camptothecin