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Randomized Phase II Trial of Combination Chemotherapy With Panitumumab or Bevacizumab for Patients With Inoperable Cholangiocarcinoma Without KRAS Mutations

Phase 2
18 Years
Open (Enrolling)

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Trial Information

Randomized Phase II Trial of Combination Chemotherapy With Panitumumab or Bevacizumab for Patients With Inoperable Cholangiocarcinoma Without KRAS Mutations

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The fraction of patients alive and without progression at 6 months

Outcome Time Frame:

6 months from enrollment date

Safety Issue:


Principal Investigator

Anders Jakobsen, MD, DMSc

Investigator Role:

Study Chair

Investigator Affiliation:

Department of Oncology, Vejle Hospital


Denmark: Danish Dataprotection Agency

Study ID:




Start Date:

September 2010

Completion Date:

August 2013

Related Keywords:

  • Cholangiocarcinoma
  • Cholangiocarcinoma
  • Inoperable
  • KRAS mutation
  • Biological treatment
  • Combination chemotherapy
  • Monoclonal antibody
  • Cholangiocarcinoma