Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma

Brief Title

Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma

Official Title

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 Phase

Phase 2

Study Type

Interventional

Primary Outcome

Progression free survival

Secondary Outcome

 Response rate

Condition

Cholangiocarcinoma

Intervention

Gemcitabine, Oxaliplatin, Capecitabine,

Study Arms / Comparison Groups

 KRAS wildtype

Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

72

Start Date

September 2008

Completion Date

March 2016

Primary Completion Date

March 2016

Eligibility 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
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Anders Jakobsen, DMSc, , 

Location Countries

Denmark

Location Countries

Denmark

NCT ID

NCT00779454

Organization ID

GOX-P

Secondary IDs

S-20080081

Responsible Party

Sponsor

Study Sponsor

Vejle Hospital

Study Sponsor

Anders Jakobsen, DMSc, Study Chair, Vejle Hospital, Vejle, Denmark

Verification Date

June 2016