A Phase I Trial of LY231514 With Irinotecan Administered Intravenously Every 21 Days in Patients With Metastatic Cancer
OBJECTIVES: I. Determine the maximum tolerated dose of LY231514 followed by irinotecan in
patients with metastatic cancer. II. Determine the quantitative and qualitative toxicity of
LY231514 in combination with irinotecan in these patients. III. Assess plasma
pharmacokinetics in these patients treated with this regimen. IV. Document any antitumor
activity of this regimen in these patients.
OUTLINE: This is a dose escalation study. Patients receive LY231514 IV over 10 minutes
followed by irinotecan IV over 90 minutes on day 1. Courses repeat every 3 weeks in the
absence of disease progression and unacceptable toxicity. Cohorts of 3-6 patients each
receive escalating doses of LY231514 and irinotecan. If escalation of one drug in the
combination results in unacceptable dose limiting toxicity (DLT), the drug is not escalated
further. Instead, the dose of that drug is decreased to its safe dose, and the second drug
is escalated until unacceptable DLT results. If DLT occurs in 2 of up to 6 patients at any
level, dose escalation is stopped. The maximum tolerated dose is defined as the highest dose
at which fewer than 2 of 6 patients experience DLT during courses 1 or 2.
PROJECTED ACCRUAL: Up to 42 patients will be accrued for this study.
Primary Purpose: Treatment
Thomas R. Johnson, 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|