A Phase I Trial of Lometrexol Sodium and Paclitaxel Adminsitered Intravenously Every 21 Days in Conjunction With Oral Folic Acid in Patients With Solid Tumors
- Determine the maximum tolerated dose and recommended phase II study dose of lometrexol
and paclitaxel when combined with folic acid in patients with locally advanced or
metastatic solid tumors.
- Determine the quantitative and qualitative toxic effects of this regimen in these
- Determine the plasma concentrations of lometrexol and paclitaxel and relate their
pharmacokinetics to toxicity outcome in these patients.
- Determine the antitumor activity of this regimen in these patients.
OUTLINE: This is a multicenter, dose-escalation study of lometrexol and paclitaxel.
Patients receive lometrexol IV over 30-60 seconds immediately followed by paclitaxel IV over
3 hours on day 1. Patients also receive oral folic acid beginning 7 days before
lometrexol/paclitaxel and continuing for 14 days. Treatment repeats every 21 days in the
absence of disease progression or unacceptable toxicity.
Doses of lometrexol and paclitaxel are escalated sequentially. Cohorts of 3-6 patients
receive escalating doses of lometrexol and paclitaxel until the maximum tolerated dose (MTD)
is determined. The MTD is defined as the dose at which at least 2 of 6 patients experience
dose-limiting toxicity. Six to twelve additional patients are treated at the recommended
phase II study dose (dose immediately preceding the MTD).
Patients are followed every 3 months.
PROJECTED ACCRUAL: Approximately 12-42 patients will be accrued for this study.
Primary Purpose: Treatment
Lee S. Rosen, MD
Jonsson Comprehensive Cancer Center
United States: Federal Government
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|