Brief Title
Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma
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 Description
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Progression free survival
Secondary Outcome
Response rate
Condition
Cholangiocarcinoma
Intervention
Gemcitabine, Oxaliplatin, Capecitabine,
Study Arms / Comparison Groups
KRAS wildtype
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
72
Start Date
September 2008
Completion Date
March 2016
Primary Completion Date
March 2016
Eligibility Criteria
Inclusion Criteria: - Histologically verified adenocarcinoma arisen from gallbladder, extra or intrahepatic bile ducts or malignant cells consistent with the above and concomitant radiologic findings consistent with cholangiocarcinoma. - Curative treatment presently discounted (surgery, stereotactic radiotherapy, etc.) - KRAS analyzed and found wild-type (wt) or mutated - PS 0-2 - Evaluable disease according to RECIST criteria, i.e., the disease does not need to be measurable - Haematology: - ANC ≥ 1.5 x 10^9/l - Thrombocytes ≥ 100x10^9/l - Biochemistry: - Bilirubinaemia ≤ 3 x upper normal value - ALAT ≤ 5 x upper normal value - Creatinin ≤ upper normal value. If raised creatinin, the measured or calculated GFR must be at least 50% of the lower normal value. - Fertile women must present a negative pregnancy test and use birth control during and 3 months after treatment. The following methods are considered safe birth control: Birth control pills, coil, gestagen deposit injection, subdermal implantation, hormonal vagina ring, and transdermal deposit band-aid) - Oral and written informed consent Exclusion Criteria: - Chemotherapy within 4 weeks - Radiotherapy within 4 weeks - Immunotherapy within 4 weeks - Other concomitant experimental treatment - Known neuropathy ≥ grade 2 - Serious congruous medical disease - Other previous malignant disease within 5 years, excl. non-melanoma skin cancer and carcinoma in situ cervicis uteri - Previous serious and unexpected reactions to fluoropyrimidine treatment - Hypersensitivity to one or more of the active substances, auxiliary substances or fluoruracil - Patients with interstitial pneumonitis or pulmonary fibrosis
Gender
All
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Anders Jakobsen, DMSc, ,
Location Countries
Denmark
Location Countries
Denmark
Administrative Informations
NCT ID
NCT00779454
Organization ID
GOX-P
Secondary IDs
S-20080081
Responsible Party
Sponsor
Study Sponsor
Vejle Hospital
Study Sponsor
Anders Jakobsen, DMSc, Study Chair, Vejle Hospital, Vejle, Denmark
Verification Date
June 2016