Phase I and Pharmacokinetics Study of SarCNU in Patients With Advanced Cancers
OBJECTIVES: I. Determine the maximum tolerated dose of SarCNU in patients with advanced
solid malignancies. II. Determine the toxic effects of SarCNU in these patients. III.
Characterize the pharmacokinetic profile of this regimen in these patients. IV. Determine
any evidence of antineoplastic activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study. Patients receive oral SarCNU on days 1, 5, and 9.
Treatment continues every 4 weeks in the absence of disease progression or unacceptable
toxicity. Cohorts of 3-6 patients receive escalating doses of SarCNU until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional
patients are treated at the MTD.
PROJECTED ACCRUAL: Approximately 12-36 patients will be accrued for this study.
Primary Purpose: Treatment
Lawrence C. Panasci, MD
Jewish General Hospital
United States: Federal Government