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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.
 
ClinicalTrials.gov Identifier: NCT00779454
Recruitment Status : Completed
First Posted : October 24, 2008
Last Update Posted : February 6, 2020
Sponsor:
Information provided by (Responsible Party):
Vejle Hospital

Tracking Information
First Submitted Date  ICMJE October 22, 2008
First Posted Date  ICMJE October 24, 2008
Last Update Posted Date February 6, 2020
Study Start Date  ICMJE September 2008
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2011)
Progression free survival [ Time Frame: Up to 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 22, 2008)
Progression free survival
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2011)
  • Response rate [ Time Frame: 6 months ]
  • Overall survival [ Time Frame: 6 months. ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2008)
  • Response rate
  • Toxicity
  • Overall survival
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma
Official Title  ICMJE Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma
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).
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cholangiocarcinoma
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • KRAS wildtype
    Intervention: Drug: Panitumumab, Gemcitabine, Oxaliplatin, Capecitabine
  • KRAS mutation
    Inclusion has been completed in the KRAS mutation arm.
    Intervention: Drug: Gemcitabine, Oxaliplatin, Capecitabine,
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 9, 2017)
72
Original Estimated Enrollment  ICMJE
 (submitted: October 22, 2008)
58
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00779454
Other Study ID Numbers  ICMJE GOX-P
S-20080081
2612-3769
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vejle Hospital
Study Sponsor  ICMJE Vejle Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Anders Jakobsen, DMSc Vejle Hospital, Vejle, Denmark
PRS Account Vejle Hospital
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP