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

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

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 2007

Keywords

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

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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