Intra-hepatic Chemotherapy in Patient With Non-resectable Liver Metastases From Cholangiocarcinoma

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Cholangiocarcinoma

Intervention / Treatment
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* Drug: Oxaliplatin, capecitabine, gemcitabine, cetuximab
* Drug: Oxaliplatin, capecitabine, gemcitabine cetuximab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm chemotherapy treatment<br> | Drug: Oxaliplatin, capecitabine, gemcitabine, cetuximab<br>* Intrahepatic oxaliplatin<br>Drug: Oxaliplatin, capecitabine, gemcitabine cetuximab<br>* Oxaliplatin given intravenous<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Time from treatment start to progression or death. | 6 months after last patient included | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate. |  | 6 months after last patient included | 
| Survival |  | 6 months after last patient included | 
| Toxicity |  | 28 days after last treatment of last patient |