Lymphoma Clinical Trial
Official title:
A Phase I Study of ALIMTA Plus Oxaliplatin Administered Every Other Week in the Treatment of Patients With Metastatic Cancer
RATIONALE: Pemetrexed may stop the growth of cancer cells by blocking some of the enzymes
needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, work in different
ways to stop the growth of cancer cells, either by killing the cells or by stopping them
from dividing. Giving pemetrexed together with oxaliplatin may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of pemetrexed given
together with oxaliplatin in treating patients with metastatic solid tumors or lymphoma.
OBJECTIVES:
Primary
- 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
lymphoma.
Secondary
- Determine the quantitative and qualitative toxicities of this regimen in these
patients.
- 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
toxicity.
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
thereafter.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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