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Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma

Phase 2
18 Years
80 Years
Open (Enrolling)

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Trial Information

Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma

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 radical, and most patients with cholangiocarcinoma are therefore candidates
for chemotherapy.

In Denmark the combination therapy of Gemcitabine, Oxaliplatin and Capecitabine has been
used in recent years. Based on experience with gastrointestinal tumors, however, there seems
to be an effect of new biological substances, including EGFR antibodies. There are casuistic
reports on the specific effect of a monoclonal antibody against EGFR in cholangiocarcinoma.

The effect of EGF is mediated through an intracellular pathway involving the KRAS protein.
It has been shown that a mutation of KRAS causes the EGF system to be constantly activated.
Effect in patients with a KRAS mutation is therefore not to be expected. Approximately 50%
of the patients present this mutation.

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

- 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

- Patients with interstitial pneumonitis or pulmonary fibrosis

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival

Outcome Time Frame:

Up to 6 months

Safety Issue:



Denmark: National Board of Health

Study ID:

EudraCT 2008-002367-14



Start Date:

September 2008

Completion Date:

July 2014

Related Keywords:

  • Cholangiocarcinoma
  • KRAS wild-type
  • Cholangiocarcinoma
  • Inoperable
  • Cholangiocarcinoma