Docetaxel and exisulind in previously treated non-small cell lung cancer (NSCLC) patients: a multicenter, phase II clinical trial.

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.

• Authors: Glen J Weiss, Everett E Vokes, Paul A Bunn Jr, Lyn Magree, Jason Rusk, Don Albert, Karen Kelly
• Journal: Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer (J Thorac Oncol) Vol. 2 Issue 10 Pg. 933-8 (Oct 2007) ISSN: 1556-1380 [Electronic] United States
• PMID: 17909356 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Taxoids
• Docetaxel
• Sulindac
• sulindac sulfone

Topics

• Adenocarcinoma (drug therapy, pathology, radiotherapy)
• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Carcinoma, Large Cell (drug therapy, pathology, radiotherapy)
• Carcinoma, Non-Small-Cell Lung (drug therapy, pathology, radiotherapy, therapy)
• Carcinoma, Squamous Cell (drug therapy, pathology, radiotherapy)
• Combined Modality Therapy
• Docetaxel
• Dose-Response Relationship, Drug
• Female
• Humans
• Lung Neoplasms (drug therapy, pathology, radiotherapy, therapy)
• Male
• Maximum Tolerated Dose
• Middle Aged
• Neoplasm Staging
• Prognosis
• Radiotherapy Dosage
• Remission Induction
• Sulindac (administration & dosage, analogs & derivatives)
• Survival Rate
• Taxoids (administration & dosage)
• Treatment Outcome