A Phase 1 interventional study of oxaliplatin and pemetrexed disodium in Lymphoma and Solid Tumor, sponsored by Vanderbilt-Ingram Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-04-18.
Sponsored by Vanderbilt-Ingram Cancer Center · Phase 1, Interventional, and Treatment
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
Secondary
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 25 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Vanderbilt-Ingram Cancer Center is the lead sponsor of 220 studies on the registry; 32 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 18 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Metastatic disease
No clinically relevant third-space fluid collections
Exclusion Criteria:
PRIOR CONCURRENT THERAPY:
Drug: oxaliplatin · Drug: pemetrexed disodium
75-100 mg/m2 iv infusion Approximately 2 hours beginning approximately 30 minutes after the end of ALIMTA infusion on Day 1 of a 14-days cycle
Also known as: Elaxtin
a novel antifolate with multiple targets.
Maximum tolerated dose
Recommended phase II dose
Toxicity
Efficacy
This study is completed, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.
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Vanderbilt-Ingram Cancer Center