Overview

Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma

Status:
Completed
Trial end date:
2016-03-01
Target enrollment:
0
Participant gender:
All
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 antibody to the treatment of patients with wild-type Kirsten rat sarcoma viral oncogene homolog (KRAS).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Vejle Hospital
Treatments:
Capecitabine
Gemcitabine
Oxaliplatin
Panitumumab
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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