A Phase I/IIA, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Crossover, Dose-Escalation, Safety Study of the Chemot

A Phase I/IIA, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Crossover, Dose-Escalation, Safety Study of the Chemotherapy Modulator PHY906 in Patients with Advanced Colorectal Cancer

Closed; study dates February 2002 to May 2003

This study was conducted in 5 sites across the United States with the objectives of evaluating:

a) the safety and tolerability of PHY906 + irinotecan (CPT-11)/5-fluorouracil (FU)/leucovorin (LV) or PHY906 + CPT-11 alone at three different doses of PHY906;

b) the effects of PHY906 on the pharmacokinetics of CPT-11 and FU; and

c) the effects of PHY906 on reducing the toxic and adverse event profile of CPT-11

Conclusions from the 18 enrolled are:

a) diarrhea frequency lower on PHY906 than on placebo at first dose;

b) vomiting frequency lower on PHY906 than on placebo at second dose;

c) loperamide hydrochloride received less frequently when patients on PHY906;

d) PHY906 at first dose does not affect the pharmacokinetic parameters of 5-FU or CPT-11 and its active metabolite SN-38; and

e) stable disease at study end = 59%; partial response at study end = 29%

Ferrell MP, Kummar S.  Phase I/IIA randomized study of PHY906, a novel herbal agent, as a modulator of chemotherapy in patients with advanced colorectal cancer.  Clin Colorectal Cancer.  2003 Feb;2(4):253-6.