Docetaxel and exisulind in previously treated non-small cell lung cancer (NSCLC) patients

A multicenter, phase II clinical trial

Glen J. Weiss, Everett E. Vokes, Paul A. Bunn, Lyn Magree, Jason Rusk, Don Albert, Karen Kelly

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

PURPOSE: This multicenter, phase II clinical trial was conducted to evaluate the activity of the combination of docetaxel and exisulind in advanced non-small cell lung cancer (NSCLC) patients who failed a prior platinum-containing regimen. PATIENTS AND METHODS: Patients with measurable disease and adequate organ function received exisulind (250 mg) given orally, twice daily, and docetaxel (36 mg/m) administered intravenously on days 1, 8, and 15 of a 4-week cycle for up to six cycles. In the absence of disease progression or intolerable side effects, patients continued taking 250 mg of exisulind orally, twice daily. RESULTS: Thirty-three patients (median age 60 years; range 34-77; median performance status 1) were enrolled. There were no objective responses documented. Sixteen patients [48%, 95% confidence interval (CI): 31%-66%] had stable disease after 8 weeks of treatment. Median progression-free survival (PFS) was 2.1 months (95% CI: 1.5-3.2 months); median overall survival time was 8.0 months (range 0.2-25.9 months). Toxicity was moderate, with dose adjustment for adverse event/toxicity required for docetaxel or exisulind in 13 (39.3%) patients. Grade 3/4 lymphopenia, neutropenia, and anemia occurred in 48.5%, 12.1%, and 9.1% of patients, respectively. Grade 3 or greater toxicity was seen in 12.1%, 6.1%, and 3% of patients for nausea/vomiting, dyspnea, and abdominal pain, respectively. CONCLUSIONS: Treatment with exisulind and weekly docetaxel was not active in NSCLC patients who failed a prior platinum-containing regimen. Further study of this combination does not seem warranted.

Original languageEnglish (US)
Pages (from-to)933-938
Number of pages6
JournalJournal of Thoracic Oncology
Volume2
Issue number10
DOIs
StatePublished - Oct 2007
Externally publishedYes

Fingerprint

docetaxel
Phase II Clinical Trials
Non-Small Cell Lung Carcinoma
Platinum
Confidence Intervals
sulindac sulfone
Lymphopenia
Neutropenia

Keywords

  • Chemotherapy
  • Docetaxel
  • Exisulind
  • Non-small cell lung cancer

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine

Cite this

Docetaxel and exisulind in previously treated non-small cell lung cancer (NSCLC) patients : A multicenter, phase II clinical trial. / Weiss, Glen J.; Vokes, Everett E.; Bunn, Paul A.; Magree, Lyn; Rusk, Jason; Albert, Don; Kelly, Karen.

In: Journal of Thoracic Oncology, Vol. 2, No. 10, 10.2007, p. 933-938.

Research output: Contribution to journalArticle

Weiss, Glen J. ; Vokes, Everett E. ; Bunn, Paul A. ; Magree, Lyn ; Rusk, Jason ; Albert, Don ; Kelly, Karen. / Docetaxel and exisulind in previously treated non-small cell lung cancer (NSCLC) patients : A multicenter, phase II clinical trial. In: Journal of Thoracic Oncology. 2007 ; Vol. 2, No. 10. pp. 933-938.
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abstract = "PURPOSE: This multicenter, phase II clinical trial was conducted to evaluate the activity of the combination of docetaxel and exisulind in advanced non-small cell lung cancer (NSCLC) patients who failed a prior platinum-containing regimen. PATIENTS AND METHODS: Patients with measurable disease and adequate organ function received exisulind (250 mg) given orally, twice daily, and docetaxel (36 mg/m) administered intravenously on days 1, 8, and 15 of a 4-week cycle for up to six cycles. In the absence of disease progression or intolerable side effects, patients continued taking 250 mg of exisulind orally, twice daily. RESULTS: Thirty-three patients (median age 60 years; range 34-77; median performance status 1) were enrolled. There were no objective responses documented. Sixteen patients [48{\%}, 95{\%} confidence interval (CI): 31{\%}-66{\%}] had stable disease after 8 weeks of treatment. Median progression-free survival (PFS) was 2.1 months (95{\%} CI: 1.5-3.2 months); median overall survival time was 8.0 months (range 0.2-25.9 months). Toxicity was moderate, with dose adjustment for adverse event/toxicity required for docetaxel or exisulind in 13 (39.3{\%}) patients. Grade 3/4 lymphopenia, neutropenia, and anemia occurred in 48.5{\%}, 12.1{\%}, and 9.1{\%} of patients, respectively. Grade 3 or greater toxicity was seen in 12.1{\%}, 6.1{\%}, and 3{\%} of patients for nausea/vomiting, dyspnea, and abdominal pain, respectively. CONCLUSIONS: Treatment with exisulind and weekly docetaxel was not active in NSCLC patients who failed a prior platinum-containing regimen. Further study of this combination does not seem warranted.",
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AU - Bunn, Paul A.

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AB - PURPOSE: This multicenter, phase II clinical trial was conducted to evaluate the activity of the combination of docetaxel and exisulind in advanced non-small cell lung cancer (NSCLC) patients who failed a prior platinum-containing regimen. PATIENTS AND METHODS: Patients with measurable disease and adequate organ function received exisulind (250 mg) given orally, twice daily, and docetaxel (36 mg/m) administered intravenously on days 1, 8, and 15 of a 4-week cycle for up to six cycles. In the absence of disease progression or intolerable side effects, patients continued taking 250 mg of exisulind orally, twice daily. RESULTS: Thirty-three patients (median age 60 years; range 34-77; median performance status 1) were enrolled. There were no objective responses documented. Sixteen patients [48%, 95% confidence interval (CI): 31%-66%] had stable disease after 8 weeks of treatment. Median progression-free survival (PFS) was 2.1 months (95% CI: 1.5-3.2 months); median overall survival time was 8.0 months (range 0.2-25.9 months). Toxicity was moderate, with dose adjustment for adverse event/toxicity required for docetaxel or exisulind in 13 (39.3%) patients. Grade 3/4 lymphopenia, neutropenia, and anemia occurred in 48.5%, 12.1%, and 9.1% of patients, respectively. Grade 3 or greater toxicity was seen in 12.1%, 6.1%, and 3% of patients for nausea/vomiting, dyspnea, and abdominal pain, respectively. CONCLUSIONS: Treatment with exisulind and weekly docetaxel was not active in NSCLC patients who failed a prior platinum-containing regimen. Further study of this combination does not seem warranted.

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