Phase II study of CI-958 in colorectal cancer

Purpose: We completed a phase II trial of CI-958 (NSC 635371) in patients w ith advanced colorectal cancer given at a dose of 700 mg/m(2) every 21 days . Methods. All 15 patients had metastatic disease and had been previously t reated with one 5-fluorouracil-based regimen in an adjuvant (six) or metast atic (nine) setting. Results: None of the patients treated with CI-958 had an objective response to treatment. Median survival was 4.8 months after th e start of treatment. Leukopenia was the major toxicity, but no patient exp erienced febrile neutropenia. An acute febrile reaction was seen after infu sion in four of the first nine patients treated. This was abrogated by pret reatment with dexamethasone in the remaining patients. Conclusions: CI-958 was not effective at this dose and schedule in patients with previously tre ated advanced colorectal cancer.