Pemetrexed and Oxaliplatin in Treating Patients With Metastatic Solid Tumors or Lymphoma
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.
Drug: pemetrexed disodium
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of ALIMTA Plus Oxaliplatin Administered Every Other Week in the Treatment of Patients With Metastatic Cancer|
- Maximum tolerated dose [ Designated as safety issue: Yes ]
- Recommended phase II dose [ Designated as safety issue: Yes ]
- Toxicity [ Designated as safety issue: Yes ]
- Efficacy [ Designated as safety issue: No ]
|Study Start Date:||May 2004|
|Study Completion Date:||November 2007|
|Primary Completion Date:||May 2007 (Final data collection date for primary outcome measure)|
|Experimental: Therapeutic Intervention||
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
Other Name: ElaxtinDrug: pemetrexed disodium
a novel antifolate with multiple targets.
Other Name: pemetrexed disodium
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00470405
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|Principal Investigator:||Mace L. Rothenberg, MD, FACP||Vanderbilt-Ingram Cancer Center|