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Title: Combination of Pemetrexed and Oxaliplatin Shows Activity in Metastatic Colorectal Cancer Patients: Presented at ASCO-GI

"Combination of Pemetrexed and Oxaliplatin Shows Activity in Metastatic Colorectal Cancer Patients: Presented at ASCO-GI"

By Ed Susman SAN FRANCISCO, CA -- January 31, 2006 -- The combination of pemetrexed (Alimta) and oxaliplatin appears to be an active treatment for patients with metastatic colorectal cancer. Researchers also administered vitamin therapy to determine if a greater maximum tolerated dose of pemetrexed could be established, said George Kim, MD, assistant professor of oncology, Mayo Clinic School of Medicine, Jacksonville, Florida. The dose-escalating trial included 22 patients who received doses of pemetrexed up to 900 mg/m[² and up to 130 mg/m² of oxaliplatin. Patients also were given dietary folic acid 350 mcg daily and vitamin B12 1000-mcg intramuscular injections every 9 weeks.

"The highest planned dose -- 900 mg/m² of pemetrexed and 130 mg/m² of oxaliplatin -- was defined as the maximum tolerated dose in the this study," Dr. Kim said on January 28^th at the 42^nd Annual Meeting of the American Society of Clinical Oncology - Gastrointestinal Cancer Symposium (ASCO-GI).

"The broad antifolate inhibition of pemetrexed may result in greater activity than observed with fluoropyrimidines," Dr. Kim said in his poster presentation. "The combination of pemetrexed and oxaliplatin may lead to improvements in response rates and survival when compared with standard FOLFOX regimens."

FOLFOX regimens combine 5-fluorouracil, folinic acid (leucovorin), and oxaliplatin.

Dr. Kim and his colleagues observed a complete response in 1 of 22 patients in the study and 8 achieved partial responses. Eight other patients achieved disease stabilization through at least 1 assessment.

"The median survival was 17.8 months with a 65% 1-year survival," he said.

In addition, the regimen appeared to be well tolerated. Half the patients had grade 3 or 4 neutropenia. Dr. Kim said there were no instances of dose-limiting toxicity.

A phase 2 portion of the study will compare the combination to the modified FOLFOX regimen, FOLFOX6, with both study arms containing bevacizumab.

Every 21-day administration of pemetrexed and oxaliplatin -- without the need of an infusion pump -- is more convenient than FOLFOX regimens, Dr. Kim said.

The 3-day symposium was cosponsored by the American Society for Therapeutic Radiology and Oncology, the American Gastroenterological Association, and the Society of Surgical Oncology.

[Presentation title: Pemetrexed (ALIMTA) and Oxaliplatin for Metastatic Colorectal Cancer: Results of Phase 1 Mayo Cancer Center Research Consortium Trial. Abstract 272]

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