title: Phase II trial of intravenous CI-1042 in patients with metastatic colorectal cancer.
abstract: OBJECTIVE
  To evaluate the antitumor activity, safety, immune response, and replication of CI-1042 (ONYX-015), an E1B 55-kd gene-deleted replication-selective adenovirus, administered intravenously to patients with metastatic colorectal cancer
  
  
  METHODS
  Eighteen patients with metastatic colorectal cancer for whom prior chemotherapy failed were enrolled onto an open-label, multicenter, phase II study. CI-1042 was administered intravenously at a dose of 2 x 1012 viral particles every 2 weeks. Patients were evaluated for tumor response and toxicity; in addition, blood samples were taken for adenovirus DNA and neutralizing antibody analysis.
  
  
  RESULTS
  Common toxicities included flu-like symptoms, nausea, and emesis. All 18 patients eventually were removed from study because of progressive disease. Seven patients were assessed as having stable disease after 2 months of treatment, whereas two patients were considered to have stable disease after 4 months. Detectable circulating CI-1042 DNA was identified in 36% of patients 72 hours after last infusion, which is suggestive of ongoing viral replication.
  
  
  CONCLUSIONS
  In this phase II study, intravenous CI-1042 was administered safely to patients with advanced colorectal cancer. Toxicity was manageable, consisting primarily of flu-like symptoms. Stable disease was experienced by seven patients for 11 to 18 weeks.
authors.affiliation: Pfizer Global Research and Development, 2800 Plymouth Rd, Ann Arbor, MI 48105, USA. oday.hamid@pfizer.com
authors.forename: Oday
authors.initials: O
authors.lastname: Hamid
authors.forename: Mary L
authors.initials: ML
authors.lastname: Varterasian
authors.forename: Scott
authors.initials: S
authors.lastname: Wadler
authors.forename: J Randolph
authors.initials: JR
authors.lastname: Hecht
authors.forename: Al
authors.initials: A
authors.lastname: Benson
authors.forename: Evanthia
authors.initials: E
authors.lastname: Galanis
authors.forename: Margaret
authors.initials: M
authors.lastname: Uprichard
authors.forename: Charles
authors.initials: C
authors.lastname: Omer
authors.forename: Paul
authors.initials: P
authors.lastname: Bycott
authors.forename: Robert C
authors.initials: RC
authors.lastname: Hackman
authors.forename: Anthony F
authors.initials: AF
authors.lastname: Shields
mesh_terms: D000256:Adenoviridae / Q000276:immunology; D000328:Adult; D000368:Aged; D000956:Antigens, Viral / Q000032:analysis; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001344:Autopsy; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D014018:Tissue Distribution; D017211:Treatment Failure; D014765:Viral Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000956:Antigens, Viral; D000970:Antineoplastic Agents; D014765:Viral Vaccines; C464532:dl1520