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  • Title: Phase II trial of PALA in combination with 5-fluorouracil in advanced pancreatic cancer.
    Author: Rosvold E, Schilder R, Walczak J, DiFino SM, Flynn PJ, Banerjee TK, Heim WJ, Engstrom PF, Ozols RF, O'Dwyer PJ.
    Journal: Cancer Chemother Pharmacol; 1992; 29(4):305-8. PubMed ID: 1537077.
    Abstract:
    Phosphonacetyl-L-aspartate (PALA), in inhibitor of aspartate transcarbamylase that depletes uridine nucleotide pools, selectively potentiates the antitumor activity of 5-fluorouracil (5-FU) in preclinical models. Due to the promising results we obtained using PALA/5-FU in colorectal cancer, we performed a phase II trial in patients presenting with advanced pancreatic cancer. PALA was given intravenously at 250 mg/m2 on day 1, followed 24 h later by 2,600 mg/m2 5-FU given by 24-h infusion. Treatments were repeated weekly. A total of 41 patients who had not previously undergone chemotherapy were entered in the trial; of these, 35 were evaluable for response. Toxicity was generally mild to moderate; neurotoxicity (13/35) and diarrhea (8/35) predominated. Among the 35 patients, 1 achieved a complete response and 4, a partial remission, for an overall response rate of 14%. The median survival was 5.1 months. Pretreatment with PALA alone was not sufficient to enhance the activity of 5-FU in pancreatic cancer.
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