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

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

Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer (2007-04-06)
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
ABSTRACT

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. 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. 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). 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.

MATERIALS
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Brand
Product Description

Sigma-Aldrich
Sulindac sulfone, ≥94% (HPLC), (solid or powder)