Combination Chemotherapy Plus Panitumumab or Bevacizumab for Inoperable Cholangiocarcinoma Without KRAS Mutations
This trial is active, not recruiting.
|Treatments||gemcitabine, oxaliplatin, capecitabine, panitumumab, bevacizumab|
|Start date||September 2010|
|End date||March 2016|
|Trial size||78 participants|
|Trial identifier||NCT01206049, 2010-020385-13|
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.
|Endpoint classification||efficacy study|
|Intervention model||crossover assignment|
The fraction of patients alive and without progression at 6 months
time frame: 6 months from enrollment date
Response rate before cross-over
time frame: 6 months after enrollment or earlier in case of progression
time frame: 6 months
Progression free survival and response rate after cross-over
time frame: 6 months
Male or female participants at least 18 years old.
- 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
- 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
|Official title||Randomized Phase II Trial of Combination Chemotherapy With Panitumumab or Bevacizumab for Patients With Inoperable Cholangiocarcinoma Without KRAS Mutations|
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