Phase II trial of intravenous CI-1042 in patients with metastatic colorectal cancer

Oday Hamid*, Mary L. Varterasian, Scott Wadler, J. Randolph Hecht, Al Benson, Evanthia Galanis, Margaret Uprichard, Charles Omer, Paul Bycott, Robert C. Hackman, Anthony F. Shields

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

124 Scopus citations


Purpose: 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 Patients and 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 × 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. Conclusion: 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.

Original languageEnglish (US)
Pages (from-to)1498-1504
Number of pages7
JournalJournal of Clinical Oncology
Issue number8
StatePublished - Apr 15 2003

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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