patients with cholangiocarcinoma after progression. When patients with cholangiocarcinoma cannot be operated, we cannot cure them. The purpose of oncologic treatment is to prolong survival and to enhance quality of life. When first line treatment fails, we do not have a standard treatment for these patients. Many of the patients are still in a good condition and we hope for this group that our treatment can main stain their good condition and prolong survivalreatment. MedDRA version: 14.1 Level
Conditions
Interventions
Trade Name: irinotecan
Product Name: Irinotecan
Product Code: L01XX19
Pharmaceutical Form: Infusion
Trade Name: gemcitabin "Accord"
Product Name: gemcitabin
Pharmaceutical Form: Infusion
Trade Name:
Sponsors
Herlev University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria • Informed consent • Age > 18 years • Performance status 0-1 • Patient with histological cholangiocarcinoma or malign cells and a CT-scan in accordance to a cholangiocarcinoma. • Liver metastases not suitable for surgery or other local treatment • Have received first line treatment for cholangiocarcinoma. • Neutrofile granulocytes ? 1.5 x 109/l and thrombocytes ? 75 x 109/l • Bilirubine ? 2.0 x UNL (upper normal limit). • Creatinine-clearence ? 30 ml/min 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 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35
Exclusion criteria
Exclusion criteria: Exclusion criteria • Other current or prior malignant disease in the past five years, except adequately treated and cured carcinoma in situ of the cervix or squamous cell carcinoma of the skin. • The patient is not allowed to participate in other clinical trials with antineoplastic treatment.. • Other severe medical conditions • 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 • Known prior hypersensitivity reactions to the agents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary endpoint Progression free survival ;Secondary Objective: Secondary endpoints a) Tumour response (RECIST version 1.1) b) Survival c) 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 metabolites and clinical endpoints (response, time to progression, survival) ;Primary end point(s): Primary endpoint Progression free survival Secondary endpoints a) Tumour response (RECIST version 1.1) b) Survival c) Toxicity ;Timepoint(s) of evaluation of this end point: time to progression | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints a) Tumour response (RECIST version 1.1) b) Survival c) Toxicity ;Timepoint(s) of evaluation of this end point: 6 month after last patient was included | — |
Countries
Denmark
Contacts
Public ContactOncology Department
Herlev University Hospital
Outcome results
None listed