Chemotherapy with gemcitabine, capecitabine, irinotecan and bevacizumab to patients with cholangiocarcinoma after progression on first line treatment.
- Conditions
- 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: 14.1Level: LLTClassification code 10008594Term: Cholangiocarcinoma non-resectableSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-001559-11-DK
- Lead Sponsor
- Herlev University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
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
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary endpoint<br><br>Progression free survival <br>;Secondary Objective: Secondary endpoints<br>a) Tumour response (RECIST version 1.1)<br>b) Survival <br>c) 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 metabolites and clinical endpoints (response, time to progression, survival)<br><br>;Primary end point(s): Primary endpoint<br><br>Progression free survival <br><br>Secondary endpoints<br>a) Tumour response (RECIST version 1.1)<br>b) Survival <br>c) Toxicity<br> <br>;Timepoint(s) of evaluation of this end point: time to progression
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Secondary endpoints<br>a) Tumour response (RECIST version 1.1)<br>b) Survival <br>c) Toxicity<br>;Timepoint(s) of evaluation of this end point: 6 month after last patient was included