Inoperable cholangiocarcinoma without KRAS mutations MedDRA version: 16.1 Level: LLT Classification code 10008594 Term: Cholangiocarcinoma non-resectable System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Gemzar
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: GEMCITABINE HYDROCHLORIDE
CAS Number: 122111-03-9
Concentration unit: mg/ml milligram(s)/milli
Sponsors
Vejle Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Other malignant disease within 5 years prior to enrolment except form 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 haemorrhage or increased risk of haemorrhage (e.g. tumor invasion in large vessels or known øsofagusvaricer) • Known hypersensitivity to panitumumab, bevacizumab or any of the auxilliary agents • Grade IV fistulas • Uncontrolled hypertension, i.e. symptomatic hypertension or non-medically stabilised hypertension >160/100 • Haemoptysis > 2.5 ml within 2 weeks prior to enrolment • Previous serious and unexpected reactions or know hypersensitivity to one or more of the applied cytostatics. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 45
Exclusion criteria
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 diease making the patient unfit for study participation as assessed by investigator • Other malignant disease within 5 years prior to enrolment except form 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 wounds or ulcers • Active haemorrhage or increased risk of haemorrhage (e.g. tumor invasion in large vessels or known esophagus varices) • Known hypersensitivity to panitumumab, bevacizumab or any of the auxilliary agents • Grade IV fistulas • Uncontrolled hypertension, i.e. symptomatic hypertension or non-medically stabilised hypertension >160/100 • Haemoptysis > 2.5 ml within 2 weeks prior to enrolment • Previous serious and unexpected reactions or known hypersensitivity to one or more of the applied cytostatics.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the rate of progression free survival at 6 months in a comparable population of patients with inoperable cholangiocarcinoma treated with either GOC and panitumumab or GOC and bevacizumab.;Secondary Objective: ? Response rate ? Overall survival ? Toxicity ? Progression free survival and response rate after crossover ;Primary end point(s): The fraction of patients alive and without progression after 6 months | — |
Countries
Denmark, Sweden
Outcome results
None listed