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% |
