Intra-hepatic chemotherapy with oxaliplatin every second week in combination with systemic gemcitabine and capecitabine and in patients with a KRAS-wild type tumour in combination with cetuximab in patient with non-resectable liver metastases from cholangiocarcinoma. A phase II trial.
- Conditions
- Patient with non-resectable liver metastases from cholangiocarcinoma. A phase II trial.MedDRA version: 12.1Level: LLTClassification code 10008594Term: Cholangiocarcinoma non-resectable
- Registration Number
- EUCTR2010-020188-19-DK
- Lead Sponsor
- Oncology Department
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion criteria
•Informed consent
•Age > 18 years
•Performance status 0-1; expected survival = 3 months
•Patient with histologically or cytologically adenocacinoma developed from cells in the gall bladder, extra- or intrahepatic bile ducts or malignant cells consistent with above mentioned and radiologic findings consistent with choloangiocarcinoma
•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
•Neutrofile granulocytes ? 1.5 x 109/l og thrombocytes ? 100 x 109/l
•Bilirubine ? 2.0 x UNL (upper normal limit).
•Creatinine-clearence ? 30 ml/min.
•INR < 2.
•Intrahepatic treatment can be accomplished
•The patients is approved by a multidisciplinary team
•The treatment is approved by ”Second Opinion udvalget”
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•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 fluorpyrimidin
•Known prior hypersensitivity reactions to the agents
•Interstitial pneumonitis or pulmonary fibrosis
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: Secondy endpoints<br>Time to<br>a) Intrahepatic progression <br>b) Extrahepatic progression<br>c) Number of patients suitable for local therapy (radiofrequency) <br>d) Survival <br>e) Toxicity<br> <br>Correlation between biomarkers in tissue and blood (e.g. genes: mRNA and microRNA, SNP array profiles; proteins: p53, P1NP, P3NP, TIMP-1, IL-6, YKL-40, EGFR and VEGF and metabolittes and clinical endpoints (response, time to progression, survival)<br><br>;Main Objective: Primary endpoint<br><br>Response rate<br>Number of patients with complete or partial response in the liver (RECIST version 1.1)<br><br>;Primary end point(s): Response rate<br>Number of patients with complete or partial response in the liver (RECIST version 1.1)<br>
- Secondary Outcome Measures
Name Time Method