Clinical trial NCT01206049: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cholangiocarcinoma
Keywords: Cholangiocarcinoma
Inoperable
KRAS mutation
Biological treatment
Combination chemotherapy
Monoclonal antibody
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
First posted: 2010-09-21
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The fraction of patients alive and without progression at 6 months
timeFrame: 6 months from enrollment date
Secondary outcomes:
measure: Response rate before cross-over
timeFrame: 6 months after enrollment or earlier in case of progression
measure: Overall survival
timeFrame: 6 months
measure: Progression free survival and response rate after cross-over
timeFrame: 6 months
Other outcomes:
Locations:
city: Vejle
country: Denmark
facility: Department of Oncology, Vejle Hospital
Study officials:
affiliation: Department of Oncology, Vejle Hospital
name: Anders Jakobsen, MD, DMSc
role: STUDY_CHAIR
References: