Gemcitabine and irinotecan in locally advanced or metastatic biliary cancer

preliminary report.

Pankaj Bhargava, Chirag R. Jani, Diane M. Savarese, Judith L. O'Donnell, Keith E. Stuart, Caio M. Rocha Lima

Research output: Contribution to journalArticle

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Abstract

Chemotherapy has had limited success in biliary tract cancer. Of the newer agents, gemcitabine (Gemzar) and irinotecan (CPT-11, Camptosar) both have single-agent activity in patients with advanced disease. We conducted a phase II trial to study the efficacy and toxicity of the combination of gemcitabine plus irinotecan in patients with locally advanced or metastatic biliary tract cancer. The study has enrolled 14 patients with histologically or cytologically documented cancer of the biliary tract or gallbladder with bidimensionally measurable disease, Eastern Cooperative Oncology Group performance status 0 or 1, decompressed biliary tree, and no prior exposure to chemotherapy. Gemcitabine at 1,000 mg/m2 and irinotecan at 100 mg/m2 were both administered on days 1 and 8, every 21 days. In patients who had less than grade 3 hematologic and less than grade 2 nonhematologic toxicity following cycle 1, the dose of irinotecan was increased to 115 mg/m2 for subsequent cycles. A total of 65 cycles of chemotherapy have been administered, with an average of 4.5 cycles per patient (range: 1 to 11 cycles). The median treatment duration was 3 months (range: 0.75 to 8 months). An objective partial response was determined radiographically in two patients (14%) while stable disease for periods ranging from 4 to 11.5 months was noted in six patients (43%). Toxicity consisted of grade 3/4 neutropenia in seven patients (50%) with no episodes of febrile neutropenia, grade 3/4 thrombocytopenia in four (28%), grade 3 diarrhea in two (14%), and grade 3 nausea in one patient. The combination of gemcitabine plus irinotecan appears to possess modest clinical activity, and it is well tolerated in patients with advanced biliary cancer. Patient accrual is ongoing to this study.

Original languageEnglish
Pages (from-to)23-26
Number of pages4
JournalOncology (Williston Park, N.Y.)
Volume17
Issue number9 Suppl 8
StatePublished - Sep 1 2003

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irinotecan
gemcitabine
Biliary Tract Neoplasms
Drug Therapy

ASJC Scopus subject areas

  • Oncology

Cite this

Bhargava, P., Jani, C. R., Savarese, D. M., O'Donnell, J. L., Stuart, K. E., & Rocha Lima, C. M. (2003). Gemcitabine and irinotecan in locally advanced or metastatic biliary cancer: preliminary report. Oncology (Williston Park, N.Y.), 17(9 Suppl 8), 23-26.

Gemcitabine and irinotecan in locally advanced or metastatic biliary cancer : preliminary report. / Bhargava, Pankaj; Jani, Chirag R.; Savarese, Diane M.; O'Donnell, Judith L.; Stuart, Keith E.; Rocha Lima, Caio M.

In: Oncology (Williston Park, N.Y.), Vol. 17, No. 9 Suppl 8, 01.09.2003, p. 23-26.

Research output: Contribution to journalArticle

Bhargava, P, Jani, CR, Savarese, DM, O'Donnell, JL, Stuart, KE & Rocha Lima, CM 2003, 'Gemcitabine and irinotecan in locally advanced or metastatic biliary cancer: preliminary report.', Oncology (Williston Park, N.Y.), vol. 17, no. 9 Suppl 8, pp. 23-26.
Bhargava P, Jani CR, Savarese DM, O'Donnell JL, Stuart KE, Rocha Lima CM. Gemcitabine and irinotecan in locally advanced or metastatic biliary cancer: preliminary report. Oncology (Williston Park, N.Y.). 2003 Sep 1;17(9 Suppl 8):23-26.
Bhargava, Pankaj ; Jani, Chirag R. ; Savarese, Diane M. ; O'Donnell, Judith L. ; Stuart, Keith E. ; Rocha Lima, Caio M. / Gemcitabine and irinotecan in locally advanced or metastatic biliary cancer : preliminary report. In: Oncology (Williston Park, N.Y.). 2003 ; Vol. 17, No. 9 Suppl 8. pp. 23-26.
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