Cholangiocarcinoma
Conditions
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.
Interventions
DRUGOxaliplatin, capecitabine, gemcitabine, cetuximab
Intrahepatic oxaliplatin
DRUGOxaliplatin, capecitabine, gemcitabine cetuximab
Oxaliplatin given intravenous
Sponsors
Dorte Nielsen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 6 months after last patient included | Time from treatment start to progression or death. |
Secondary
| Measure | 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 |
Countries
Denmark
Outcome results
None listed