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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Vejle Hospital
Sponsor:
Information provided by (Responsible Party):
Vejle Hospital
ClinicalTrials.gov Identifier:
NCT01206049
First received: September 20, 2010
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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
Cholangiocarcinoma
Drug: Gemcitabine
Drug: Oxaliplatin
Drug: Capecitabine
Drug: Panitumumab
Drug: Bevacizumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate before cross-over [ Time Frame: 6 months after enrollment or earlier in case of progression ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Progression free survival and response rate after cross-over [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 78
Study Start Date: September 2010
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: December 2014 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01206049

Contacts
Contact: Anders Jakobsen, MD, DMSc +45 7940 6010 anders.jakobsen@rsyd.dk
Contact: Henrik Jensen, MD, PhD lars.henrik.jensen@rsyd.dk

Locations
Denmark
Department of Oncology, Vejle Hospital Recruiting
Vejle, Denmark, DK-7100
Principal Investigator: Henrik Jensen, MD, PhD         
Sub-Investigator: John Ploen, MD         
Sponsors and Collaborators
Vejle Hospital
Investigators
Study Chair: Anders Jakobsen, MD, DMSc Department of Oncology, Vejle Hospital
  More Information

No publications provided

Responsible Party: Vejle Hospital
ClinicalTrials.gov Identifier: NCT01206049     History of Changes
Other Study ID Numbers: 2010-020385-13
Study First Received: September 20, 2010
Last Updated: March 28, 2014
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Health and Medicines Authority
Denmark: Ethics Committee

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

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

ClinicalTrials.gov processed this record on July 28, 2014