A phase II trial of perifosine in locally advanced, unresectable, or metastatic pancreatic adenocarcinoma

Robert De W. Marsh, C. M.Rocha Lima, D. E. Levy, E. P. Mitchell, K. M. Rowland, A. B. Benson

Research output: Contribution to journalArticle

48 Scopus citations

Abstract

BACKGROUND: Perifosine, a heterocyclic alkylphosphocholine signal transduction inhibitor, has activity against multiple cell types in vitro. This is a phase II study to determine activity and toxicity of perifosine in pancreatic adenocarcinoma. PATIENTS AND METHODS: Previously untreated patients with locally advanced, unresectable, or metastatic pancreatic adenocarcinoma, performance status Eastern Cooperative Oncology Group 0 or 1, were enrolled. An oral loading dose of 900 mg was followed by 100 mg per day until progression or unacceptable toxicity. Response criteria in solid tumors (RECIST) methodology and a 2-stage design were used. Suspension could occur for inadequate response in the first cohort or for more than 25% grade 3 or greater toxicity. RESULTS: Ten patients were enrolled. Six received 1 month and 4 received 2 months of treatment. Four discontinued therapy as a result of progression and 2 because of clinical deterioration. Three died during treatment. One patient had stable disease but discontinued therapy as a result of unacceptable adverse events (95% confidence interval: 0.3-45%). There were no objective responses and all patients died of progressive disease. Median overall and progression-free survival was 1.85 months (95% confidence interval: 0.9-2.7) and 1.5 months (95% confidence interval: 0.9-1.9) respectively. CONCLUSION: The study was suspended and subsequently terminated as a result of unacceptable adverse events during the first stage. Perifosine does not appear to be worthy of further study in this group of patients.

Original languageEnglish (US)
Pages (from-to)26-31
Number of pages6
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Volume30
Issue number1
DOIs
StatePublished - Feb 1 2007

Keywords

  • Adenocarcinoma
  • Alkylphosphocholine
  • Pancreas
  • Perifosine
  • Phase II
  • Unresectable

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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