A Phase I, Pharmacokinetic, and Treatment Duration and Escalation Study of Intravenous Intoplicine Administered as a 5 to 21-Day Continuous Infusion Every 4 Weeks
OBJECTIVES: I. Determine the intolerable dose level of intoplicine in patients with locally
advanced or metastatic cancer. II. Determine recommended phase II dose of intoplicine in
these patients. III. Determine the principal and dose limiting toxicities of intoplicine in
these patients, and determine the duration and reversibility of the toxicities. IV.
Determine the magnitude of plasma concentrations that are achieved and maintained on this
regimen and relate this parameter to toxicity outcome and antitumor activity. V. Determine
preliminary evidence of antitumor activity of intoplicine in these patients.
OUTLINE: This is a dose escalation study. The first 3 patients receive intoplicine IV by
continuous infusion for 5 days. Treatment is repeated every 28 days in the absence of
disease progression or unacceptable toxicity. Subsequent cohorts of 3-6 patients receive
escalating doses of intoplicine, first by increasing the number of days that the drug is
infused to 10, 15, and 21, then by increasing the dosage and keeping the infusion time
constant at 21 days. The intolerable dose level is defined as the lowest dose at which at
least 2 of 3 or 6 patients experience dose limiting toxicity during course 1 or 2.
PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study.
Primary Purpose: Treatment
Gayle Cook, RN
United States: Federal Government
|Brooke Army Medical Center||Fort Sam Houston, Texas 78234-6200|
|San Antonio Cancer Institute||San Antonio, Texas 78229-3264|