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Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00779454
Recruitment Status : Completed
First Posted : October 24, 2008
Last Update Posted : February 6, 2020
Information provided by (Responsible Party):
Vejle Hospital

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 antibody to the treatment of patients with wild-type Kirsten rat sarcoma viral oncogene homolog (KRAS).

Condition or disease Intervention/treatment Phase
Cholangiocarcinoma Drug: Gemcitabine, Oxaliplatin, Capecitabine, Drug: Panitumumab, Gemcitabine, Oxaliplatin, Capecitabine Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma
Study Start Date : September 2008
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Progression free survival [ Time Frame: Up to 6 months ]

Secondary Outcome Measures :
  1. Response rate [ Time Frame: 6 months ]
  2. Overall survival [ Time Frame: 6 months. ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00779454

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Vejle Hospital, Dept. of Oncology
Vejle, Denmark, DK-7100
Sponsors and Collaborators
Vejle Hospital
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Study Chair: Anders Jakobsen, DMSc Vejle Hospital, Vejle, Denmark
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Vejle Hospital Identifier: NCT00779454    
Other Study ID Numbers: GOX-P
First Posted: October 24, 2008    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: June 2016
Keywords provided by Vejle Hospital:
KRAS wild-type
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological