Phase I Dose Escalation Trial of Biweekly Alimta (With Vitamin Supplementation) in Combination With Taxotere in Advanced Solid Tumor Patients
- To determine the maximum-tolerated dose of the combination of pemetrexed disodium and
docetaxel when administered on a day 1 and day 15 dosing schedule.
- To specifically characterize the toxicity profile for the combination of biweekly
pemetrexed disodium and docetaxel.
- To investigate the antitumor activity in patients with advanced solid tumors as
measured by RECIST criteria for patients with measurable disease or tumor markers for
patients with non-measurable disease.
- To determine the recommended phase II dose of the combination of pemetrexed disodium
and docetaxel on a biweekly dosing schedule.
OUTLINE: This is a dose-escalation study.
Patients receive pemetrexed disodium IV over 10 minutes and docetaxel IV on days 1 and 15.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum-tolerated dose (MTD) of combination ALIMTA and Taxotere
From first dose of the study drug until 30 days after the last administration of study medication
Lee Cranmer, MD, PhD
University of Arizona
United States: Food and Drug Administration
|Arizona Cancer Center at University of Arizona Health Sciences Center||Tucson, Arizona 85724|