title: CPT-11 plus cisplatin in patients with advanced, untreated gastric or gastroesophageal junction carcinoma: results of a phase II study.
abstract: BACKGROUND
  This Phase II study assessed the response rate and toxicity profile of the combination CPT-11 and cisplatin administered weekly to patients with untreated, advanced adenocarcinoma of the stomach or the gastroesophageal junction.
  
  
  METHODS
  Patients with histologic proof of adenocarcinoma of the stomach or the gastroesophageal junction with adequate liver, kidney, and bone marrow functions were treated with 65 mg/m(2) CPT-11 plus 30 mg/m(2) cisplatin, both administered intravenously 1 day per week for 4 consecutive weeks, followed by a recovery period of 2 consecutive weeks. The response rate, time to disease progression, survival, and toxic effects were analyzed.
  
  
  RESULTS
  Thirty-six of 38 registered patients (95%) were assessable. The median number of 6-week cycles per patient was 2.5 (range, 1-7 6-week cycles). Four patients (11%) achieved a complete response, and 17 patients (47%) had a partial response for an overall response rate of 58%. The median time to progression of carcinoma was 24 weeks, and the median survival was 9 months (range, 1-23+ months). There was one treatment-related death. Major toxic effects included diarrhea, neutropenia, and fatigue. Ninety percent of all planned doses were delivered on time; however, 53 of 79 canceled or delayed weekly doses (66%) occurred in the third or fourth week of the therapy cycle.
  
  
  CONCLUSIONS
  The combination of CPT-11 and cisplatin is active against gastric or gastroesophageal adenocarcinoma and needs to be studied further. A modification in doses and schedules may be warranted to make the regimen more tolerable to patients. The addition of other active drugs or radiation therapy to this regimen would be of interest.
authors.affiliation: Department of Gastrointestinal Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas 77030, USA. jajani@mdanderson.org
authors.forename: Jaffer A
authors.initials: JA
authors.lastname: Ajani
authors.forename: Jackie
authors.initials: J
authors.lastname: Baker
authors.forename: Peter W T
authors.initials: PW
authors.lastname: Pisters
authors.forename: Linus
authors.initials: L
authors.lastname: Ho
authors.forename: Paul F
authors.initials: PF
authors.lastname: Mansfield
authors.forename: Barry W
authors.initials: BW
authors.lastname: Feig
authors.forename: Chusilp
authors.initials: C
authors.lastname: Charnsangavej
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000494:pharmacology*; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000494:pharmacology*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000494:pharmacology*; D002945:Cisplatin / Q000008:administration & dosage / Q000494:pharmacology*; D003967:Diarrhea / Q000139:chemically induced; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D000972:Antineoplastic Agents, Phytogenic; D000077146:Irinotecan; D002945:Cisplatin; D002166:Camptothecin