CPT-11 for Bile-Duct and Gallbladder Carcinoma: A Phase II North Central Cancer Treatment Group (NCCTG) Study.

Publication/Presentation Date

1-1-2002

Abstract

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.

Volume

32

Issue

2-3

First Page

107

Last Page

114

ISSN

1537-3649

Disciplines

Medical Sciences | Medicine and Health Sciences

PubMedID

12794246

Peer Reviewed for front end display

Peer-Reviewed

Department(s)

Department of Medicine, Hematology-Medical Oncology Division, Department of Medicine Faculty

Document Type

Article

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