A Phase I Study of ALIMTA Plus Oxaliplatin Administered Every Other Week in the Treatment of Patients With Metastatic Cancer
- Determine the maximum tolerated dose and the recommended phase II dose of pemetrexed
disodium in combination with oxaliplatin in patients with metastatic solid tumors or
- Determine the quantitative and qualitative toxicities of this regimen in these
- Determine, preliminarily, the efficacy of this regimen in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive pemetrexed disodium IV over 10 minutes and oxaliplatin IV over 2 hours on
day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable
Cohorts of 3-6 patients receive escalating doses of pemetrexed disodium and oxaliplatin
until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once
the MTD is determined, the recommended phase II dose will be identified.
After completion of study treatment, patients are followed at 30 days and then periodically
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose
Mace L. Rothenberg, MD, FACP
Vanderbilt-Ingram Cancer Center
United States: Federal Government
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|