Patient with non-resectable liver metastases from cholangiocarcinoma. A phase II trial. MedDRA version: 12.1 Level: LLT Classification code 10008594 Term: Cholangiocarcinoma non-resectable
Conditions
Interventions
Trade Name: Xeloda
Product Name: capecitabine
Pharmaceutical Form: Tablet
INN or Proposed INN: CAPECITABINE
CAS Number: 154361-50-9
Trade Name: Eloxatin
Product Name: oxaliplatin
Pharmaceutical Form:
Sponsors
Oncology Department
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 fluorpyrimidin • Known prior hypersensitivity reactions to the agents • Interstitial pneumonitis or pulmonary fibrosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Secondy endpoints Time to a) Intrahepatic progression b) Extrahepatic progression c) Number of patients suitable for local therapy (radiofrequency) d) Survival e) Toxicity 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) ;Main Objective: Primary endpoint Response rate Number of patients with complete or partial response in the liver (RECIST version 1.1) ;Primary end point(s): Response rate Number of patients with complete or partial response in the liver (RECIST version 1.1) | — |
Countries
Denmark
Outcome results
None listed