Docetaxel and Exisulind in Previously Treated Non-small Cell Lung Cancer (NSCLC) Patients: A Multicenter, Phase II Clinical Trial

• Published in: Journal of thoracic oncology 2007-10, Vol.2 (10), p.933-938
• Main Authors: Weiss, Glen J., Vokes, Everett E., Bunn, Paul A., Magree, Lyn, Rusk, Jason, Albert, Don, Kelly, Karen
• Format: Article
• Language: English
• Subjects: Adenocarcinoma - drug therapy; Adenocarcinoma - pathology; Adenocarcinoma - radiotherapy; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Carcinoma, Large Cell - drug therapy; Carcinoma, Large Cell - pathology; Carcinoma, Large Cell - radiotherapy; Carcinoma, Non-Small-Cell Lung - drug therapy; Carcinoma, Non-Small-Cell Lung - pathology; Carcinoma, Non-Small-Cell Lung - radiotherapy; Carcinoma, Non-Small-Cell Lung - therapy; Carcinoma, Squamous Cell - drug therapy; Carcinoma, Squamous Cell - pathology; Carcinoma, Squamous Cell - radiotherapy; Chemotherapy; Combined Modality Therapy; Docetaxel; Dose-Response Relationship, Drug; Exisulind; Female; Humans; Lung Neoplasms - drug therapy; Lung Neoplasms - pathology; Lung Neoplasms - radiotherapy; Lung Neoplasms - therapy; Male; Maximum Tolerated Dose; Middle Aged; Neoplasm Staging; Non-small cell lung cancer; Prognosis; Radiotherapy Dosage; Remission Induction; Sulindac - administration & dosage; Sulindac - analogs & derivatives; Survival Rate; Taxoids - administration & dosage; Treatment Outcome
• ISSN: 1556-0864; 1556-1380
• DOI: 10.1097/JTO.0b013e3181462051

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 with measurable disease and adequate organ function received exisulind (250 mg) given orally, twice daily, and docetaxel (36 mg/m2) 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. 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. 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.