Annals of Surgical Oncology

, Volume 14, Issue 11, pp 3202–3209 | Cite as

A Phase II Study of Gemcitabine and Capecitabine in Advanced Cholangiocarcinoma and Carcinoma of the Gallbladder: A Single-Institution Prospective Study

  • Renuka V. Iyer
  • John Gibbs
  • Boris Kuvshinoff
  • Marwan Fakih
  • James Kepner
  • Nancy Soehnlein
  • David Lawrence
  • Milind M. Javle
Gastrointestinal Oncology

Abstract

Aim

To determine the clinical benefit response (CBR), time to tumor progression (TTP), overall survival, and effect on quality of life (QOL) of gemcitabine and capecitabine in patients with advanced biliary cancer.

Methods

Gemcitabine (1000 mg/m2 IV over 30 minutes on days 1 and 8) and capecitabine (650 mg/m2 orally twice daily for 14 days) were administered and repeated every 21 days. All patients completed the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire and Pancreatic Cancer Module (EORTC QLQ-C30-PAN 26) questionnaire on day 1 of each cycle. Cumulative QOL scores were calculated. The two-stage design required 17 patients to evaluate the confirmed response at nine weeks.

Results

Twelve patients with a median age of 54 years were enrolled. A median of eight cycles per patient were completed. With a median follow-up of 18.2 months, the CBR (two partial response and five stable disease) was 58% [95% confidence interval (CI) 28–85%]. Four out of seven patients with CBR had no decline in QOL with chemotherapy. The probability of survival at one year was 0.58. Median TTP and overall survival were 9.0 and 14.0 months, respectively. Nine patients had grade 3 or 4 toxicities. There were no treatment-related deaths.

Conclusions

Gemcitabine and capecitabine at this dose and schedule are well tolerated and effective and may offer clinical benefit and maintain QOL in patients with advanced biliary cancer. This regimen merits further investigation in the neoadjuvant setting.

Keywords

Biliary tract cancer Capecitabine Gemcitabine Quality of life (QOL) Chemotherapy 

Notes

Acknowledgements

We thank Elli Lilly Pharmaceuticals for their generous support of this research and Dr Patrick Creaven for kindly reviewing this manuscript.

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Copyright information

© Society of Surgical Oncology 2007

Authors and Affiliations

  • Renuka V. Iyer
    • 1
    • 5
  • John Gibbs
    • 2
  • Boris Kuvshinoff
    • 2
  • Marwan Fakih
    • 1
  • James Kepner
    • 3
  • Nancy Soehnlein
    • 1
  • David Lawrence
    • 4
  • Milind M. Javle
    • 1
  1. 1.Department of Medical OncologyRoswell Park Cancer InstituteBuffaloUSA
  2. 2.Department of Surgical OncologyRoswell Park Cancer InstituteBuffaloUSA
  3. 3.American Cancer SocietyAtlantaUSA
  4. 4.Department of BiostatisticsRoswell Park Cancer InstituteBuffaloUSA
  5. 5.Roswell Park Cancer InstituteBuffaloUSA

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