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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Start Date
May 1, 2004
Primary Completion Date
May 1, 2007
Completion Date
November 1, 2007
Last Updated
April 18, 2011
25
ACTUAL participants
oxaliplatin
DRUG
pemetrexed disodium
DRUG
Lead Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
NCT05529069
NCT05720117
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07388563