Status:
COMPLETED
Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma
Lead Sponsor:
Vejle Hospital
Conditions:
Cholangiocarcinoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The purpose of this study is partly to continue the good experience the investigators have with chemotherapy and partly to optimize treatment of inoperable cholangiocarcinoma by adding a biological an...
Detailed Description
Cholangiocarcinoma is a relatively rare disease. In Denmark approximately 150 patients are diagnosed each year. A small part of the patients can be offered surgery, but the operation will rarely be ra...
Eligibility Criteria
Inclusion
- Histologically verified adenocarcinoma arisen from gallbladder, extra or intrahepatic bile ducts or malignant cells consistent with the above and concomitant radiologic findings consistent with cholangiocarcinoma.
- Curative treatment presently discounted (surgery, stereotactic radiotherapy, etc.)
- KRAS analyzed and found wild-type (wt) or mutated
- PS 0-2
- Evaluable disease according to RECIST criteria, i.e., the disease does not need to be measurable
- Haematology:
- ANC ≥ 1.5 x 10\^9/l
- Thrombocytes ≥ 100x10\^9/l
- Biochemistry:
- Bilirubinaemia ≤ 3 x upper normal value
- ALAT ≤ 5 x upper normal value
- Creatinin ≤ upper normal value. If raised creatinin, the measured or calculated GFR must be at least 50% of the lower normal value.
- Fertile women must present a negative pregnancy test and use birth control during and 3 months after treatment. The following methods are considered safe birth control: Birth control pills, coil, gestagen deposit injection, subdermal implantation, hormonal vagina ring, and transdermal deposit band-aid)
- Oral and written informed consent
Exclusion
- Chemotherapy within 4 weeks
- Radiotherapy within 4 weeks
- Immunotherapy within 4 weeks
- Other concomitant experimental treatment
- Known neuropathy ≥ grade 2
- Serious congruous medical disease
- Other previous malignant disease within 5 years, excl. non-melanoma skin cancer and carcinoma in situ cervicis uteri
- Previous serious and unexpected reactions to fluoropyrimidine treatment
- Hypersensitivity to one or more of the active substances, auxiliary substances or fluoruracil
- Patients with interstitial pneumonitis or pulmonary fibrosis
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00779454
Start Date
September 1 2008
End Date
March 1 2016
Last Update
February 6 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Vejle Hospital, Dept. of Oncology
Vejle, Denmark, DK-7100