Brief Title
Combination Chemotherapy Plus Panitumumab or Bevacizumab for Inoperable Cholangiocarcinoma Without KRAS Mutations
Official Title
Randomized Phase II Trial of Combination Chemotherapy With Panitumumab or Bevacizumab for Patients With Inoperable Cholangiocarcinoma Without KRAS Mutations
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
The fraction of patients alive and without progression at 6 months
Secondary Outcome
Response rate before cross-over
Condition
Cholangiocarcinoma
Intervention
Gemcitabine
Study Arms / Comparison Groups
Combination chemotherapy + panitumumab
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
88
Start Date
September 2010
Completion Date
March 2016
Primary Completion Date
March 2016
Eligibility 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Anders Jakobsen, MD, DMSc, ,
Location Countries
Denmark
Location Countries
Denmark
Administrative Informations
NCT ID
NCT01206049
Organization ID
2010-020385-13
Responsible Party
Sponsor
Study Sponsor
Vejle Hospital
Study Sponsor
Anders Jakobsen, MD, DMSc, Study Chair, Department of Oncology, Vejle Hospital
Verification Date
June 2016