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.
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Additional participating institutions include: CentraCare Clinic, St. Cloud, MN 56301 (Harold E. Windschitl, MD); Saskatchewan Cancer Centre, Saskatoon, Saskatchewan, Canada S7N 4H4, Allan Blair Cancer Centre, Regina, Saskatchewan, Canada S4T 7T1 (Muhammad Salim, MD); Toledo Community Hospital Oncology Program CCOP, Toledo, OH (Paul L. Schaefer, MD); Wichita Community Clinical Oncology Program, Wichita, KS 67214-3882 (Shaker R. Dakhil, MD); Scottsdale CCOP, Scottsdale, AZ 85259-5404 (Tom R. Fitch, MD); Ann Arbor Regional CCOP, Ann Arbor, MI 48106 (Philip J. Stella, MD); Medcenter One Health Systems, Bismarck, ND 58506 (Ferdinand Addo, MD); Cedar Rapids Oncology Project CCOP, Cedar Rapids, IA 52403 (Martin Wiesenfeld, MD); Meritcare Hospital CCOP, Fargo, ND 58122 (Ralph Levitt, MD); Altru Health Systems, Grand Forks, ND 58201 (Daniel J. Walsh, MD); Siouxland Hematology-Oncology Associates, Sioux City, IA 51105 (John C. Michalak, MD); Sioux Community Cancer Consortium, Sioux Falls, SD 57105 (Loren K. Tschetter, MD); Missouri Valley Cancer Consortium, Omaha, NE 68131 (James A. Mailliard, MD).
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Alberts, S.R., Fishkin, P.A., Burgart, L.J. et al. CPT-11 for bile-duct and gallbladder carcinoma. Int J Gastrointest Canc 32, 107–114 (2002). https://doi.org/10.1385/IJGC:32:2-3:107
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DOI: https://doi.org/10.1385/IJGC:32:2-3:107