Status:
COMPLETED
Combination Chemotherapy Plus Panitumumab or Bevacizumab for Inoperable Cholangiocarcinoma Without KRAS Mutations
Lead Sponsor:
Vejle Hospital
Conditions:
Cholangiocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 com...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT01206049
Start Date
September 1 2010
End Date
March 1 2016
Last Update
March 13 2017
Active Locations (1)
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1
Department of Oncology, Vejle Hospital
Vejle, Denmark, DK-7100