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

被引:5
作者
Weiss, Glen J.
Vokes, Everett E.
Bunn, Paul A., Jr.
Magree, Lyn
Rusk, Jason
Albert, Don
Kelly, Karen
机构
[1] Univ Kansas, Med Ctr, Kansas City, KS 66160 USA
[2] TGen Clin Res Serv Scottsdale Healthcare, Scottsdale, AZ USA
[3] Univ Colorado, Ctr Canc, Aurora, CO USA
[4] Univ Chicago, Med Ctr, Chicago, IL 60637 USA
[5] OSI Pharmaceut Inc, Melville, NY USA
关键词
non-small cell lung cancer; Exisulind; docetaxel; chemotherapy;
D O I
10.1097/JTO.0b013e3181462051
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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(2)) 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 (Cl): 31%-66%] had stable disease after 8 weeks of treatment. Median progression-free survival (PFS) was 2.1 months (95% Cl: 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.
引用
收藏
页码:933 / 938
页数:6
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