CPT-11 for Bile-Duct and Gallbladder Carcinoma: A Phase II North Central Cancer Treatment Group (NCCTG) Study.
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.
Published In/Presented At
Alberts, S. R., Fishkin, P. A., Burgart, L. J., Cera, P. J., Mahoney, M. R., Morton, R. F., & ... Goldberg, R. M. (2002). CPT-11 for Bile-Duct and Gallbladder Carcinoma: a Phase II North Central Cancer Treatment Group (NCCTG) Study. International Journal Of Gastrointestinal Cancer, 32(2-3), 107-114.
Medical Sciences | Medicine and Health Sciences
Peer Reviewed for front end display
Department of Medicine, Hematology-Medical Oncology Division, Department of Medicine Faculty