Phase I and Pharmacokinetic Study of FB-642 Administered Orally on a Weekly Schedule to Patients With Advanced Solid Tumors
OBJECTIVES: I. Determine the maximum tolerated dose of oral carbendazim in patients with
advanced solid tumors. II. Determine the qualitative and quantitative toxic effects of oral
carbendazim in these patients. III. Characterize the pharmacokinetic profile of oral
carbendazim in these patients. IV. Assess the recommended dose of oral carbendazim to be
used in phase II studies. V. Determine preliminary evidence of antitumor activity of this
regimen in these patients.
OUTLINE: This is a dose escalation study. Patients receive oral carbendazim weekly for 3
weeks followed by 1 week of rest. Treatment is repeated every 28 days in the absence of
disease progression or unacceptable toxic effects. Cohorts of 3-6 patients receive
escalating doses of carbendazim. If dose limiting toxicity (DLT) is seen in 1 of 3 patients
treated at a given dose level, 3 additional patients will be entered at the same dose level.
Dose escalation continues until the maximum tolerated dose (MTD) is determined. The MTD is
defined as the dose preceding that at which 2 of 6 patients experience DLT. Patients are
followed for up to 30 days posttreatment.
PROJECTED ACCRUAL: Up to 35 patients will be accrued for this study.
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Anthony W. Tolcher, MD
San Antonio Cancer Institute
United States: Federal Government
|Brooke Army Medical Center||Fort Sam Houston, Texas 78234-6200|
|San Antonio Cancer Institute||San Antonio, Texas 78229-3264|