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OpenTrials
Completed

NCT Number: NCT00832689

Irinotecan, Gemcitabine, Chemotherapy for Biliary Tract Cancer

The study hypothesis is that chemotherapy of irinotecan and gemcitabine will improve local control of cancer and prolong survival in patients with inoperable biliary tract cancer.

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Key information

Conditions

Biliary Tract Cancer Biliary Tract Diseases Biliary Tract Neoplasms Digestive System Diseases Digestive System Neoplasms Neoplasms Neoplasms by Site

Age range

17 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Severance hospital

Seoul, 120750, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically or cytologically confirmed inoperable biliary tract cancer
  • Age: 18 ~75 years old
  • Performance status: ECOG 0-2
  • Hematopoietic:
  • Granulocyte count at least 1,500/mm3
  • Platelet count at least 100,000/mm3
  • Hepatic:
  • Bilirubin No greater than 2 fold the upper normal limit
  • AST/ALT : No greater than 3 fold the upper normal limit
  • Renal:
  • Creatinine - no greater than 1.5 mg/dL
  • Not pregnant
  • No other serious medical or psychiatric illness that would preclude giving informed consent or limit
  • No prior chemotherapy within 6 months
  • No other concurrent anticancer radiotherapy within 6 months

Treatment and study plan

Irinotecan and Gemcitabine

Drug

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Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jan 30, 2009
Registry last updated
Mar 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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