Clinical Trial: Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma

Brief Summary: The purpose of this study is partly to continue the good experience the investigators have with chemotherapy and partly to optimize treatment of inoperable cholangiocarcinoma by adding a biological antibody to the treatment of patients with wild-type Kirsten rat sarcoma viral oncogene homolog (KRAS).

Detailed Summary:

Cholangiocarcinoma is a relatively rare disease. In Denmark approximately 150 patients are diagnosed each year. A small part of the patients can be offered surgery, but the operation will rarely be radical, and most patients with cholangiocarcinoma are therefore candidates for chemotherapy.

In Denmark the combination therapy of Gemcitabine, Oxaliplatin and Capecitabine has been used in recent years. Based on experience with gastrointestinal tumors, however, there seems to be an effect of new biological substances, including EGFR antibodies. There are casuistic reports on the specific effect of a monoclonal antibody against EGFR in cholangiocarcinoma.

The effect of EGF is mediated through an intracellular pathway involving the KRAS protein. It has been shown that a mutation of KRAS causes the EGF system to be constantly activated. Effect in patients with a KRAS mutation is therefore not to be expected. Approximately 50% of the patients present this mutation.


Sponsor: Vejle Hospital

Current Primary Outcome: Progression free survival [ Time Frame: Up to 6 months ]

Original Primary Outcome: Progression free survival

Current Secondary Outcome:

  • Response rate [ Time Frame: 6 months ]
  • Overall survival [ Time Frame: 6 months. ]


Original Secondary Outcome:

  • Response rate
  • Toxicity
  • Overall survival


Information By: Vejle Hospital

Dates:
Date Received: October 22, 2008
Date Started: September 2008
Date Completion:
Last Updated: March 9, 2017
Last Verified: June 2016