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Combination Chemotherapy Plus Panitumumab or Bevacizumab for Inoperable Cholangiocarcinoma Without KRAS Mutations (GOC-B-P)

This study has been completed.
Information provided by (Responsible Party):
Vejle Hospital Identifier:
First received: September 20, 2010
Last updated: March 9, 2017
Last verified: June 2016
The purpose of this study is to determine the rate of progression free survival of patients with inoperable cholangiocarcinoma 6 months after enrollment in the study. The patients are treated with combination chemotherapy supplemented by biological agents panitumumab or bevacizumab.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial of Combination Chemotherapy With Panitumumab or Bevacizumab for Patients With Inoperable Cholangiocarcinoma Without KRAS Mutations

Resource links provided by NLM:

Further study details as provided by Vejle Hospital:

Primary Outcome Measures:
  • The fraction of patients alive and without progression at 6 months [ Time Frame: 6 months from enrollment date ]

Secondary Outcome Measures:
  • Response rate before cross-over [ Time Frame: 6 months after enrollment or earlier in case of progression ]
  • Overall survival [ Time Frame: 6 months ]
  • Progression free survival and response rate after cross-over [ Time Frame: 6 months ]

Enrollment: 88
Study Start Date: September 2010
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Combination chemotherapy + panitumumab Drug: Gemcitabine
1,000 mg/m2 on day 1 of a 2 weeks cycle
Drug: Oxaliplatin
60 mg/m2 on day 1 of a 2 weeks cycle
Drug: Capecitabine
1,000 mg/m2 x 2 daily on days 1-7 of a 2 weeks cycle
Drug: Panitumumab
6 mg/kg on day 1 of a 2 weeks cycle
Experimental: Combination chemotherapy + bevacizumab Drug: Gemcitabine
1,000 mg/m2 on day 1 of a 2 weeks cycle
Drug: Oxaliplatin
60 mg/m2 on day 1 of a 2 weeks cycle
Drug: Capecitabine
1,000 mg/m2 x 2 daily on days 1-7 of a 2 weeks cycle
Drug: Bevacizumab
10 mg/kg on day 1 of a 2 weeks cycle


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically verified adenocarcinoma arisen from gall bladder, extra- or intrahepatic bile ducts or malignant cells consistent with the above and simultaneous radiologic findings consistent with cholangiocarcinoma
  • Minimum 18 years of age
  • Curative treatment currently not an option (operation, stereotactic radiation treatment or similar)
  • KRAS analyzed and found wild-type (wt)
  • Performance status 0-2
  • Evaluable disease according to RECIST, i.e. the disease need not be measurable
  • Hematology: ANC ≥1.5x10^9/l. Thrombocytes ≥ 100x10^9/l
  • Biochemistry: Bilirubinemia ≤ 3 x upper normal level. ALAT ≤ 5 x upper normal level.
  • Creatinine ≤ upper normal level. At raised creatinine level the measured or calculated GFR must be at least 50% of the lower normal level
  • Fertile women must present a negative pregnancy test and use secure birth control during and 6 months after treatment. Men with fertile partners must also take care of secure birth control.
  • Written and orally informed consent

Exclusion Criteria:

  • Previous cytostatic treatment of inoperable cholangiocarcinoma
  • Adjuvant or neoadjuvant chemotherapy, radiation therapy or immunotherapy within 4 weeks prior to treatment start
  • Other concomitant experimental treatment
  • Severe medical disease such as considerable heart disease, serious active infection or other disease making the patient unfit for study participation as assessed by investigator
  • Other malignant disease within 5 years prior to enrolment except from non-melanotic skin cancer and carcinoma in situ cervicis uteri
  • Interstitial pneumonitis or subsequent pulmonary fibrosis
  • Pregnant or breastfeeding women
  • Large-scale surgical intervention, excision biopsy or significant traumatic lesions within 28 days prior to treatment start or presumption that large-scale surgery will become necessary during study treatment.
  • Significant non-healing wound or ulcers
  • Active hemorrhage or increased risk of hemorrhage (e.g. tumor invasion in large vessels or known esophagus varices)
  • Known hypersensitivity to panitumumab, bevacizumab or any of the auxiliary agents
  • Grade IV fistulas
  • Uncontrolled hypertension, i.e. symptomatic hypertension or non-medically stabilized hypertension >160/100
  • Haemoptysis > 2.5 ml within 2 weeks prior to enrolment
  • Previous serious and unexpected reactions or know hypersensitivity to two or more of the applied cytostatics
  Contacts and Locations
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Please refer to this study by its identifier: NCT01206049

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

Responsible Party: Vejle Hospital Identifier: NCT01206049     History of Changes
Other Study ID Numbers: 2010-020385-13
Study First Received: September 20, 2010
Last Updated: March 9, 2017

Keywords provided by Vejle Hospital:
KRAS mutation
Biological treatment
Combination chemotherapy
Monoclonal antibody

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antibodies, Monoclonal
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors processed this record on April 28, 2017