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Clinical Trial
. 2009 Dec;65(1):67-71.
doi: 10.1007/s00280-009-1003-z. Epub 2009 May 7.

Safety and pharmacokinetic trial of docetaxel plus an Astragalus-based herbal formula for non-small cell lung cancer patients

Barrie R Cassileth  1 , Naiyer Rizvi, Gary Deng, K Simon Yeung, Andrew Vickers, Stacey Guillen, Derek Woo, Marci Coleton, Mark G Kris
Affiliations
Clinical Trial

Safety and pharmacokinetic trial of docetaxel plus an Astragalus-based herbal formula for non-small cell lung cancer patients

Barrie R Cassileth et al. Cancer Chemother Pharmacol. 2009 Dec.

Abstract

Purpose: 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.

Methods: Patients with advanced NSCLC who progressed after prior platinum-containing chemotherapy were accrued and received docetaxel at 35 mg/m(2) 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.

Results: 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.

Conclusions: Jinfukang did not alter the pharmacokinetics of docetaxel nor appear to affect survival in this study.

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Figures

Fig. 1
Fig. 1
Patient flow diagram
Fig. 2
Fig. 2
Time on study (progression or withdrawal from treatment), with 95% CI N = 21
Fig. 3
Fig. 3
Time to progression, with 95% CI Patients who withdrew were censored at time of withdrawal (vertical marks)
See this image and copyright information in PMC

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