Safety and pharmacokinetic trial of docetaxel plus an Astragalus-based herbal formula for non-small cell lung cancer patients
To study a commonly used Astragalus-based herbal formula previously found effective in non-small cell lung cancer (NSCLC) on the pharmacokinetics of docetaxel in patients with NSCLC.
Patients with advanced NSCLC who progressed after prior platinum-containing chemotherapy were accrued and received docetaxel at 35 mg/m2 for 3 weeks followed by 1 week of rest. At 4 days prior to the second dosing, Jinfukang was given orally. Pharmacokinetic studies of initial-dose docetaxel (in the absence of Jinfukang) and the third dose (in the presence of Jinfukang) were compared.
Of the 24 patients enrolled, 21 started Jinfukang and docetaxel. Jinfukang had no significant impact on the pharmacokinetics of docetaxel. Median time to progression or withdrawal from treatment was 7 weeks. Twelve patients were removed from study for progression of disease; nine patients withdrew.
Jinfukang did not alter the pharmacokinetics of docetaxel nor appear to affect survival in this study.
KeywordsLung cancer Chemotherapy Docetaxel Botanicals Astragalus
This study was supported by the Memorial Sloan-Kettering Cancer Center under the Integrative Medicine/Translational Research Grant, and the National Center for Complementary and Alternative Medicine (NCCAM) and the Office of Dietary Supplements (ODS) under grant 1-P50-AT002779-01. We thank Drs. Azoli, Fiori, Krug and other oncologists of the MSKCC Thoracic Oncology Service who accrued patients to this study, James Lozada, and other research assistants for their important efforts, and our patients for their willingness to participate in this clinical trial.
Conflict of interest statement
Dr. Mark G. Kris received lecture fees from Sanofi Aventis, the maker of Docetaxel. The remaining authors have no conflict of interest regarding this study.
- 2.Liu J, Shi Z, Li H, Xu Z, Zhu Y, Zhao L et al (2001) Clinical observation on 271 cases of non-small lung cancer treated with Yifei Kangliu Yin (Jin Fu Kang). Chin J Integr Tradit West Med 7:247–250Google Scholar
- 4.Liu J PM, Li Y, Ye D, Guo Y, Li Y (2001) Clinical study of oral liquid Jin Fu Kang for the treatment of primary non-small cell lung cancer. Tumor (Shanghai) 21:463–465Google Scholar
- 7.Bhargava P, Marshall JL, Fried K, Williams M, Lefebvre P, Dahut W, Hanfelt J, Gehan E, Figuera M, Hawkins MJ, Rizvi NA (2001) Phase I and pharmacokinetic study of two sequences of gemcitabine and docetaxel administered weekly to patients with advanced cancer. Cancer Chemother Pharmacol 48:95–103PubMedCrossRefGoogle Scholar