BACKGROUND: Bile-duct and gallbladder carcinomas are rare cancers. Once they have spread beyond the point of surgical resectability, no therapies have shown meaningful long-term benefit. These cancers are typically refractory to standard chemotherapy agents. Based on preclinical work showing activity of CPT-11, we performed a phase II trial to assess its activity in patients with bile-duct or gallbladder carcinomas. METHODS: Patients with histologic or cytologic evidence of locally advanced or metastatic bile-duct or gallbladder carcinoma were potentially eligible for this study. Patients meeting study eligibility and who signed an informed consent were given CPT-11 125 mg/m2 weekly for 4 wk followed by a 2-wk break from therapy. The starting dose of CPT-11 was later reduced to 100 mg/m2 grade IV toxicity. Patients continued on treatment if they showed evidence of benefit and tolerated therapy. RESULTS: A total of 39 patients were enrolled, and 36 were evaluable. The overall confirmed response rate was 8%. One CR and two PRs were seen. A high frequency of toxicity was seen. However, no unusual or unexpected toxicities occurred. CONCLUSION: CPT-11 is ineffective therapy for patients with locally advanced or metastatic bile-duct or gallbladder carcinoma.
BACKGROUND: Bile-duct and gallbladder carcinomas are rare cancers. Once they have spread beyond the point of surgical resectability, no therapies have shown meaningful long-term benefit. These cancers are typically refractory to standard chemotherapy agents. Based on preclinical work showing activity of CPT-11, we performed a phase II trial to assess its activity in patients with bile-duct or gallbladder carcinomas. METHODS:Patients with histologic or cytologic evidence of locally advanced or metastatic bile-duct or gallbladder carcinoma were potentially eligible for this study. Patients meeting study eligibility and who signed an informed consent were given CPT-11 125 mg/m2 weekly for 4 wk followed by a 2-wk break from therapy. The starting dose of CPT-11 was later reduced to 100 mg/m2 grade IV toxicity. Patients continued on treatment if they showed evidence of benefit and tolerated therapy. RESULTS: A total of 39 patients were enrolled, and 36 were evaluable. The overall confirmed response rate was 8%. One CR and two PRs were seen. A high frequency of toxicity was seen. However, no unusual or unexpected toxicities occurred. CONCLUSION:CPT-11 is ineffective therapy for patients with locally advanced or metastatic bile-duct or gallbladder carcinoma.
Authors: B G Taal; R A Audisio; H Bleiberg; G H Blijham; J P Neijt; C H Veenhof; N Duez; T Sahmoud Journal: Ann Oncol Date: 1993-08 Impact factor: 32.976