Phase I/II study of gemcitabine and exisulind as second-line therapy in patients with advanced non-small cell lung cancer

Tien Hoang, Kyungmann Kim, Joseph Merchant, Anne M. Traynor, James McGovern, Kurt R. Oettel, Fredrico A. Sanchez, Harish G. Ahuja, Thomas A. Hensing, Martha Larson, Joan H. Schiller

Research output: Contribution to journalArticlepeer-review

6 Scopus citations


BACKGROUND: The study was designed to evaluate the safety and efficacy of exisulind, a selective apoptotic antineoplastic drug, in combination with gemcitabine as second-line therapy in patients with progressing advanced non-small cell lung cancer. METHODS: Patients whose disease progressed more than 3 months from completion of first-line chemotherapy were eligible for this phase I/II trial. Primary end points were maximally tolerated dose and time to progression. Patients in the phase I portion of the study were treated with gemcitabine (1250 mg/m) in combination with three escalated dose levels of exisulind. Treatment involved six cycles of gemcitabine and exisulind followed by exisulind maintenance. The study was subsequently expanded to phase II. RESULTS: Thirty-nine patients (15 in phase I and 24 in phase II) were treated. The regimen was well tolerated with grade 3 fatigue and grade 3 constipation being dose-limiting toxicities. The maximally tolerated dose was not reached. Dose level 3 of exisulind (250 mg twice daily) in combination with gemcitabine was used for phase II. The overall response rates were 7% (phase I), 17% (phase II), and 13% (all). Median time to progression and median and 1-year survival, respectively, were 3.7 and 9.7 months and 33% (phase I); 4.3 and 9.4 months and 41% (phase II); and 4.1 and 9.4 months and 39% (all). CONCLUSION: Although the study met its primary end point of improving time to progression (more than 4.1 months in phase II), we did not observe a clear survival advantage and thus do not plan to further investigate this schedule of gemcitabine and exisulind.

Original languageEnglish (US)
Pages (from-to)218-225
Number of pages8
JournalJournal of Thoracic Oncology
Issue number3
StatePublished - Mar 2006


  • Exisulind
  • Gemcitabine
  • Progressing non-small cell lung cancer
  • Second-line therapy

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine


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