Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Vejle Hospital Identifier:
First received: October 22, 2008
Last updated: April 7, 2016
Last verified: April 2016
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).

Condition Intervention Phase
Drug: Gemcitabine, Oxaliplatin, Capecitabine,
Drug: Panitumumab, Gemcitabine, Oxaliplatin, Capecitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma

Resource links provided by NLM:

Further study details as provided by Vejle Hospital:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 6 months. ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: September 2008
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
KRAS wildtype Drug: Panitumumab, Gemcitabine, Oxaliplatin, Capecitabine
Gemcitabine: 1,000 mg/m2 day 1 Oxaliplatin: 60 mg/m2 day 1 Capecitabine: 1,000 mg/m2 x 2 daily days 1-7 Panitumumab: 6 mg/kg day 1
KRAS mutation
Inclusion has been completed in the KRAS mutation arm.
Drug: Gemcitabine, Oxaliplatin, Capecitabine,
Gemcitabin: 1,000 mg/m2 day 1 Oxaliplatin: 60 mg/m2 day 1 Capecitabine: 1,000 mg/m2 x 2 daily days 1-7

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 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.


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00779454

Vejle Hospital, Dept. of Oncology
Vejle, Denmark, DK-7100
Sponsors and Collaborators
Vejle Hospital
Study Chair: Anders Jakobsen, DMSc Vejle Hospital, Vejle, Denmark
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Vejle Hospital Identifier: NCT00779454     History of Changes
Other Study ID Numbers: GOX-P  S-20080081  2612-3769 
Study First Received: October 22, 2008
Last Updated: April 7, 2016
Health Authority: Denmark: National Board of Health

Keywords provided by Vejle Hospital:
KRAS wild-type

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 25, 2016