Phase trial of docetaxel for cholangiocarcinoma

The authors evaluated the activity and toxicity of docetaxel given as a 1-h our infusion every 21 days in patients with unresectable cholangiocarcinoma . Seventeen patients with cytologically or histologically confirmed cholang iocarcinoma received intravenous docetaxel over 1 hour, repeated every 21 d ays. The initial dose of docetaxel was 100 mg/m(2), with a subsequent 25% d ose reduction for patients experiencing grade 3 or 4 toxicities. Treatment was continued until disease progression or occurrence of intolerable side e ffects. All patients received premedication with dexamethasone 8 mg by mout h twice daily for 5 days, starting 1 day before docetaxel infusion. Sixteen of the 17 patients were assessable for response and toxicity; one patient was removed from the trial for intercurrent illness. Thirty-eight cycles of docetaxel were delivered (median, two cycles). No complete or partial resp onses were noted. Fourteen patients had progressive disease, one patient ha d stable disease, and one patient died of septic shock shortly after starti ng treatment. Granulocytopenia was the dose-limiting toxicity. Thirteen pat ients had grade 4 granulocytopenia, 11 of whom required antibiotics for neu tropenic fever. Granulocytopenia was the only grade 4 toxicity observed. Gr ade 3 toxicities included stomatitis, anemia, fatigue, vomiting, and hypote nsion. Grade 1 or 2 toxicities included alopecia, diarrhea, peripheral edem a, myalgias, and anorexia. Administered on this dose and schedule, docetaxe l lacked activity in patients with cholangiocarcinoma. The toxicity profile . including dose-limiting granulocytopenia, has been previously described i n patients receiving docetaxel.