Brief Title
Intra-hepatic Chemotherapy in Patient With Non-resectable Liver Metastases From Cholangiocarcinoma
Official Title
Intra-hepatic Chemotherapy With Oxaliplatin Every Second Week in Combination With Systemic Gemcitabine and Capecitabine in Combination With Cetuximab in Patient With Non-resectable Liver Metastases From Cholangiocarcinoma. A Phase II Trial.
Brief Summary
A phase II trial evaluating intra-hepatic chemotherapy with oxaliplatin every second week in
combination with systemic gemcitabine and capecitabine in combination with cetuximab in
patient with non-resectable liver metastases from cholangiocarcinoma.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
PFS
Secondary Outcome
Response rate.
Condition
Cholangiocarcinoma
Intervention
Oxaliplatin, capecitabine, gemcitabine, cetuximab
Study Arms / Comparison Groups
Single arm chemotherapy treatment
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
56
Start Date
February 2, 2011
Completion Date
February 18, 2016
Primary Completion Date
February 18, 2016
Eligibility Criteria
Inclusion Criteria:• Informed consent
- Age > 18 years
- Performance status 0-1; expected survival ≥ 3 months
- Patient with histologically or cytologically adenocarcinoma developed from cells in
the gall bladder, extra- or intrahepatic bile ducts or malignant cells consistent with
above mentioned and radiologic findings consistent with cholangiocarcinoma
- Liver metastases not suitable for surgery or other local treatment
- Extrahepatic disease should be excluded by PET-CT-scan.
- Prior treatment with chemotherapy or no progression on first line treatment
- Metastases < 70 % of the liver
- neutrophile granulocytes ≥ 1.5 x 109/l og thrombocytes ≥ 100 x 109/l
- bilirubin < 2.0 x UNL (upper normal limit).
- creatinine-clearance ≥ 30 ml/min.
- INR < 2.
- Intrahepatic treatment can be accomplished
- The patients is approved by a multidisciplinary team
Exclusion Criteria:• Other current or prior malignant disease except adequately treated and
cured carcinoma in situ of the cervix or squamous cell carcinoma of the skin.
- Cytotoxic or experimental treatment within a 14 days period before start of trial
medication
- The patient is not allowed to participate in other clinical trials.
- Any clinical symptoms suggesting peripheral neuropathy grade 2
- Other severe medical conditions
- Severe cardial disease or AMI < 1 year
- Presence of diseases preventing oral therapy
- Patients with uncontrolled infection
- Pregnant or lactating women
- Women capable of childbearing not using a sufficient method of birth control
- Patients not able to understand the treatment or to collaborate
- Prior serious or unsuspected reaction after treatment with fluoropyrimidine
- Known prior hypersensitivity reactions to the agents
- Interstitial pneumonitis or pulmonary fibrosis
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Magnus Bergenfeldt, Consultan, ,
Location Countries
Denmark
Location Countries
Denmark
Administrative Informations
NCT ID
NCT01247337
Organization ID
GI 1003
Responsible Party
Sponsor-Investigator
Study Sponsor
Dorte Nielsen
Study Sponsor
Magnus Bergenfeldt, Consultan, Principal Investigator, Department og Gastroenterology
Verification Date
October 2020