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

• Status: Completed
• Trial end date: 2016-02-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dorte Nielsen
• Treatments: Capecitabine; Cetuximab; Gemcitabine; Oxaliplatin

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