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

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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.