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

Dorte Nielsen

Status and phase: Completed; Phase 2

Conditions: Cholangiocarcinoma

Treatments: Drug: Oxaliplatin, capecitabine, gemcitabine, cetuximab; Drug: Oxaliplatin, capecitabine, gemcitabine cetuximab

Study type: Interventional

Funder types: Other

Identifiers

NCT01247337

GI 1003

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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56 participants in 1 patient group

Single arm chemotherapy treatment

Experimental group

Treatment:

Drug: Oxaliplatin, capecitabine, gemcitabine cetuximab

Drug: Oxaliplatin, capecitabine, gemcitabine, cetuximab