PHASE I STUDY OF CONCOMITANT PEMETREXED AND CDDP PLUS RADIATION THERAPY IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ESOPHAGEAL OR GASTROESOPHAGEAL (GEJ) CARCINOMAS
- To establish the maximum tolerated dose of pemetrexed disodium in combination with
cisplatin and standard-dose radiotherapy in patients with stage III or IV esophageal or
gastroesophageal junction carcinoma.
- To specifically characterize the toxicity profile of this regimen.
- To investigate, preliminarily, the anti-tumor activity of this regimen, as measured by
standard response criteria (RECIST criteria), in patients with measurable disease.
OUTLINE: This is a dose-escalation study of pemetrexed disodium.
Patients receive pemetrexed disodium IV over 10 minutes on days 1, 15, and 29 and cisplatin
IV over 10 minutes on days 1, 8, 15, 22, and 29. Patients also undergo external beam
radiotherapy once daily, 5 days a week, for up to 6 weeks.
After completion of study therapy, patients are followed for 30 days and then every 3 months
for 1 year.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The maximum tolerated dose (MTD) of pemetrexed
Emad Elquza, MD
University of Arizona
United States: Food and Drug Administration
|University of Arizona Cancer Center||Tucson, Arizona 85724|