A Phase I Study of Cyclic Oral Administration of SCH 52365 for 21 of 28 Days in Patients With Advanced Solid Malignancies
OBJECTIVES: I. Determine the safety, tolerability, maximum tolerated dose, and dose limiting
toxicity of temozolomide in patients with advanced solid malignancies. II. Characterize the
single- and multiple-dose pharmacokinetics of temozolomide following oral administration in
these patients. III. Determine antitumor activity of temozolomide in these patients.
OUTLINE: This is an open label, dose escalation study. Patients receive oral temozolomide on
days 1-21. Courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity. Cohorts of 3-6 patients are treated at escalating doses of
temozolomide. The maximum tolerated dose is defined as the dose at which no more than 1 of 6
patients experiences dose limiting toxicity (DLT) during courses 1 or 2, with at least 2
patients experiencing DLT at the next higher dose level.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Anthony W. Tolcher, MD
San Antonio Cancer Institute
United States: Food and Drug Administration
|Brooke Army Medical Center||Fort Sam Houston, Texas 78234-6200|
|San Antonio Cancer Institute||San Antonio, Texas 78229-3264|