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Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma

This study is currently recruiting participants.
Verified December 2012 by Vejle Hospital
Sponsor:
Information provided by (Responsible Party):
Vejle Hospital
ClinicalTrials.gov Identifier:
NCT00779454
First received: October 22, 2008
Last updated: December 10, 2012
Last verified: December 2012
History of Changes
  Purpose

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
Cholangiocarcinoma
 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:

U.S. FDA Resources

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: July 2014
Estimated Primary Completion Date: December 2013 (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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00779454

Contacts
Contact: Anders Jakobsen, DMSc anders.jakobsen@slb.regionsyddanmark.dk
Contact: Henrik Jensen, MD +45 7940 6802 lars.henrik.jensen@slb.regionsyddanmark.dk

Locations
Denmark
The Finsen Center, Rigshospitalet Recruiting
Copenhagen, Denmark, DK-2100
Contact: Ulrik Lassen, Consult. PhD         ulassen@rh.dk    
Principal Investigator: Ulrik Lassen, Consult. PhD            
Vejle Hospital, Dept. of Oncology Recruiting
Vejle, Denmark, DK-7100
Principal Investigator: Henrik Jensen, MD, Phd            
Sub-Investigator: Anders Jakobsen, Prof., DMSc            
Sponsors and Collaborators
Vejle Hospital
  More Information

No publications provided by Vejle Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Vejle Hospital
ClinicalTrials.gov Identifier: NCT00779454     History of Changes
Other Study ID Numbers: EudraCT 2008-002367-14, S-20080081, 2612-3769
Study First Received: October 22, 2008
Last Updated: December 10, 2012
Health Authority: Denmark: National Board of Health

Keywords provided by Vejle Hospital:
KRAS wild-type
Cholangiocarcinoma
Inoperable

Additional relevant MeSH terms:
Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Capecitabine
Fluorouracil
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on May 23, 2013