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

Abstract

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 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.

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.

• Authors: Oday Hamid, Mary L Varterasian, Scott Wadler, J Randolph Hecht, Al Benson 3rd, Evanthia Galanis, Margaret Uprichard, Charles Omer, Paul Bycott, Robert C Hackman, Anthony F Shields
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 21 Issue 8 Pg. 1498-504 (Apr 15 2003) ISSN: 0732-183X [Print] United States
• PMID: 12697873 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antigens, Viral
• Antineoplastic Agents
• Viral Vaccines
• dl1520

Topics

• Adenoviridae (immunology)
• Adult
• Aged
• Antigens, Viral (analysis)
• Antineoplastic Agents (administration & dosage, adverse effects, therapeutic use)
• Autopsy
• Colorectal Neoplasms (drug therapy, pathology)
• Disease Progression
• Drug Administration Schedule
• Female
• Humans
• Male
• Middle Aged
• Tissue Distribution
• Treatment Failure
• Viral Vaccines (administration & dosage, adverse effects, therapeutic use)