Abstract
Gemcitabine has recently been compared favorably to 5-fluorouracil (5-FU) as the standard chemotherapy for advanced pancreas cancer. Based on phase I data that combining gemcitabine with 5-FU is safe and has evidence for clinical activity, a phase II trial was conducted by the Eastern Cooperative Oncology Group (ECOG). Patients with metastatic disease, good performance status and organ function were eligible and enrolled after providing informed consent. Patients were given gemcitabine (1,000 mg/m(2)) followed by 5-FU (600 mg/m(2)) weekly for 3 weeks of every 4. Of 37 patients enrolled over a 3-month period, 36 were eligible. Partial responses were seen in 5 patients (14%). Median survival was 4.4 months with a 1-year survival rate of 8.6%. A randomized trial of the combination of 5-FU and gemcitabine versus gemcitabine alone is currently accruing patients in ECOG.
Copyright 2000 S. Karger AG, Basel
Publication types
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Clinical Trial
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Clinical Trial, Phase II
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Multicenter Study
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Research Support, U.S. Gov't, Non-P.H.S.
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Research Support, U.S. Gov't, P.H.S.
MeSH terms
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Adult
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Aged
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Aged, 80 and over
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Antimetabolites, Antineoplastic / administration & dosage
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Antimetabolites, Antineoplastic / adverse effects
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Antimetabolites, Antineoplastic / therapeutic use*
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Antineoplastic Combined Chemotherapy Protocols / administration & dosage
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Antineoplastic Combined Chemotherapy Protocols / adverse effects
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Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
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Deoxycytidine / administration & dosage
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Deoxycytidine / analogs & derivatives
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Drug Administration Schedule
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Female
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Fluorouracil / administration & dosage
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Gemcitabine
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Humans
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Male
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Middle Aged
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New England
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Pancreatic Neoplasms / drug therapy*
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Pancreatic Neoplasms / pathology*
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Survival Analysis
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Treatment Outcome
Substances
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Antimetabolites, Antineoplastic
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Deoxycytidine
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Fluorouracil
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Gemcitabine