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Title of Journal: Cancer Chemother Pharmacol

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Abbravation: Cancer Chemotherapy and Pharmacology

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Springer-Verlag

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DOI

10.1016/0160-7383(92)90158-l

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1432-0843

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A phase II study of biweekly pemetrexed and gemcit

Authors: Susan F Dent Stan Gertler Shailendra Verma Roanne Segal Vince Young Rakesh Goel Oliver Keller Christina Canil Neill Iscoe
Publish Date: 2009/07/11
Volume: 65, Issue: 3, Pages: 557-
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Abstract

Pemetrexed PEM is a novel folate antimetabolite which inhibits thymidylate synthase dihydrofolate reductase and glycinamide ribonucleotide formyl transferase This phase II study was designed to assess the efficacy of Gemcitabine GEM and PEM given in a novel schedule in metastatic breast cancer MBC patientsEligible patients had MBC and received one prior chemotherapy regimen for metastatic disease Performance status PS 0–2 measurable disease RECIST criteria PEM500 mg/m2 was administered intravenously IV over 10 min prior to GEM1500 mg/m2 IV given over 30 min on day 1 every 14 daysMedian age of the 16 patients in the study was 54 years range 33–77 Fourteen patients had a PS of 0/1 and were evaluable for response There were no reported complete or partial responses seven patients with stable disease six patients with disease progression and one patient with unknown response Most common toxicities were skin rash Grade 1/28 and Grade 3/41 Grade 3/4 nonhematological toxicities were fatigue1 anorexia1 pneumonia1 peripheral ischemia1 and elevation of liver transaminases1 Three patients experienced febrile neutropenia FN This study did not meet the predefined criteria to proceed with additional accrual

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