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.

Abstract

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.

• Authors: R L Martino, T R Fleming, L M Morrell, B Ardalan, S P Richman, J S Macdonald
• Journal: Investigational new drugs (Invest New Drugs) Vol. 14 Issue 4 Pg. 419-21 ( 1996) ISSN: 0167-6997 [Print] United States
• PMID: 9157080 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Aspartic Acid
• sparfosic acid
• Phosphonoacetic Acid
• Fluorouracil

Topics

• Adenocarcinoma (drug therapy)
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Aspartic Acid (administration & dosage, adverse effects, analogs & derivatives)
• Female
• Fluorouracil (administration & dosage, adverse effects)
• Humans
• Infusions, Intravenous
• Male
• Middle Aged
• Phosphonoacetic Acid (administration & dosage, adverse effects, analogs & derivatives)
• Stomach Neoplasms (drug therapy)
• Survival Rate