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

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: NCT01206049
Recruitment Status : Completed
First Posted : September 21, 2010
Last Update Posted : March 13, 2017
Information provided by (Responsible Party):
Vejle Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Cholangiocarcinoma Drug: Gemcitabine Drug: Oxaliplatin Drug: Capecitabine Drug: Panitumumab Drug: Bevacizumab Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial of Combination Chemotherapy With Panitumumab or Bevacizumab for Patients With Inoperable Cholangiocarcinoma Without KRAS Mutations
Study Start Date : September 2010
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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): 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

Responsible Party: Vejle Hospital Identifier: NCT01206049     History of Changes
Other Study ID Numbers: 2010-020385-13
First Posted: September 21, 2010    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: June 2016

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