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.