Status:
COMPLETED
Intra-hepatic Chemotherapy in Patient With Non-resectable Liver Metastases From Cholangiocarcinoma
Lead Sponsor:
Dorte Nielsen
Conditions:
Cholangiocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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-re...
Eligibility Criteria
Inclusion
- • 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
- • 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
Key Trial Info
Start Date :
February 2 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 18 2016
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT01247337
Start Date
February 2 2011
End Date
February 18 2016
Last Update
October 5 2020
Active Locations (1)
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1
Herlev Hospital
Herlev, Denmark, 2730