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A phase I and pharmacokinetic study of exisulind and docetaxel in patients with advanced solid tumors

Samir E Witta1, Daniel L Gustafson, A Scott Pierson

  • 1University of Colorado Health Sciences Center, Denver, Colorado 80262, USA.

Clinical Cancer Research : an Official Journal of the American Association for Cancer Research
|November 10, 2004
PubMed
Abstract

Insights

This phase I study found that combining exisulind (a cancer drug) with docetaxel was safe for patients with advanced solid tumors. Further phase II trials are planned for non-small-cell lung cancer.

Area of Science:

  • Oncology
  • Pharmacology

Background:

  • Exisulind, a sulindac metabolite, inhibits cyclic GMP-phosphodiesterase and induces apoptosis.
  • Exisulind has shown tumor growth inhibition in preclinical models of various cancers.
  • Previous studies indicated survival benefits when combining exisulind and docetaxel in lung cancer models.

Purpose of the Study:

  • To evaluate the toxicity and pharmacokinetics of combining exisulind and docetaxel in patients with advanced solid tumors.
  • To establish a safe and tolerable dose for further clinical investigation.

Main Methods:

  • Phase I clinical trial involving 20 patients with advanced solid tumors.
  • Exisulind was administered orally twice daily at doses of 150-250 mg.
  • Docetaxel was administered intravenously on days 1, 8, and 15 of a 4-week cycle at doses of 30-36 mg/m2.

Main Results:

  • The combination therapy was generally well-tolerated with mild to moderate adverse events.
  • No dose-limiting toxicity was observed.
  • Grade 3 gastrointestinal toxicities occurred in 10% of cycles; neutropenia was noted in some patients at the highest docetaxel dose.
  • Exisulind plasma concentrations correlated with toxicity, but no significant pharmacokinetic interactions were observed between the drugs.
  • One-third of patients achieved stable disease, but no objective responses were recorded.

Conclusions:

  • The combination of weekly docetaxel (36 mg/m2) and daily exisulind (500 mg) is reasonably well-tolerated.
  • This combination is advancing to phase II testing, particularly for non-small-cell lung cancer.

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