Pemetrexed and oxaliplatin for metastatic colorectal cancer: results of a phase I Mayo Cancer Center Research Consortium trial, MC0248

Steven R. Alberts, George P. Kim, Michelle R. Mahoney, Michael K. Gornet, Joseph Rubin, Matthew Ames, Matthew P. Goetz, Richard M. Weinshilboum, Steven J. Nicol, Richard M. Goldberg

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

Abstract

Purpose: Pemetrexed, an antifolate involved in purine and pyrimidine formation, is a potential alternative to fluoropyrimidines in the treatment of colorectal cancer. A phase I trial was performed to establish the maximum tolerated dose (MTD) of pemetrexed and oxaliplatin when B12 and folate supplementation is used. Patients and Methods: Patients with metastatic colorectal cancer received folate (> 350 μg) daily and vitamin B 12 (1000 pg) every 9 weeks starting 7 days before chemotherapy. Pemetrexed over 10 minutes and oxaliplatin over 2 hours were given every 3 weeks in escalating dose cohorts. Results: Twenty-two patients were entered on 6 dose levels. The MTD was established at the highest dose level, pemetrexed 900 mg/m2 and oxaliplatin 130 mg/m2. Toxicities related to treatment at the MTD included grade 3 neutropenia and thrombocytopenia. For all dose levels combined, grade 3/4 toxicities included hematologic, neurologic, and gastrointestinal. Nine of 21 evaluable patients responded overall (response rate, 43%). The time to tumor progression was 11.9 months. Conclusion: The MTD was determined to be pemetrexed 900 mg/m2 and oxaliplatin 130 mg/m2 every 21 days when folate and B12 supplementation are used. Because of the observed tolerability and activity of this regimen, further evaluation is warranted.

Original languageEnglish (US)
Pages (from-to)572-577
Number of pages6
JournalClinical colorectal cancer
Volume6
Issue number8
DOIs
StatePublished - Jul 2007

Keywords

  • Chemotherapy
  • Thymidylate synthase
  • Time to progression

ASJC Scopus subject areas

  • Oncology
  • Gastroenterology

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