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Phase II trial of low-dose N-(phosphonacetyl)-disodium L-aspartic acid and high-dose 24-hour infusional 5-Fluorouracil in advanced gastric adenocarcinoma

A Southwest Oncology Group study

  • Phase II Studies
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Summary

N-(phosphonacetyl)-disodium L-aspartic acid (PALA) demonstrates a synergistic antitumor effect when combined with 5-Fluorouracil (5-FU) in in vitro studies. In a Phase II trial, 23 eligible patients with unresectable or metastatic adenocarcinoma of the stomach were treated with weekly i.v. bolus PALA (250 mg/M2) followed 24 hours later by a 24-hour infusion of 5-FU (2600 mg/M2) for an initial period of 8 weeks. No objective responses were noted. PALA and 5-FU is inactive against gastric adenocarcinoma at the doses and schedule used in this trial.

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Martino, R.L., Fleming, T.R., Morrell, L.M. et al. Phase II trial of low-dose N-(phosphonacetyl)-disodium L-aspartic acid and high-dose 24-hour infusional 5-Fluorouracil in advanced gastric adenocarcinoma. Invest New Drugs 14, 419–421 (1996). https://doi.org/10.1007/BF00180821

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  • DOI: https://doi.org/10.1007/BF00180821

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