Purpose: We completed a phase II trial of CI-958 (NSC 635371) in patients with advanced colorectal cancer given at a dose of 700 mg/m2 every 21 days.
Methods: All 15 patients had metastatic disease and had been previously treated with one 5-fluorouracil-based regimen in an adjuvant (six) or metastatic (nine) setting.
Results: None of the patients treated with CI-958 had an objective response to treatment. Median survival was 4.8 months after the start of treatment. Leukopenia was the major toxicity, but no patient experienced febrile neutropenia. An acute febrile reaction was seen after infusion in four of the first nine patients treated. This was abrogated by pretreatment with dexamethasone in the remaining patients.
Conclusions: CI-958 was not effective at this dose and schedule in patients with previously treated advanced colorectal cancer.