Klinisk prövning med kombinationsbehandling av kemoterapi och antikroppar för behandling av patienter med gallgångscancer som inte kan opereras.

• Conditions: Inoperable cholangiocarcinoma without KRAS mutations; MedDRA version: 13.1Level: LLTClassification code 10008594Term: Cholangiocarcinoma non-resectableSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2010-020385-13-SE
• Lead Sponsor: Vejle Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-07
• Last Update Posted: 5 August 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

Histologically verified adenocarcinoma arisen from gallbladder, extra-or intrahepatic bilde ducts or malignant cells consistent with the above and simultaneous radiological findings consistent with cholangiocarcinoma
- minimum 18 yeras of age
-curative treatment currently not an option(operatic, stereotactic radiation or similar
- KRAS analyzed and found wild type(wt)
-performance status 0-2
-evaluable disease according to RECIST
-Adequate hematology, liverfunctions tests and blood chemistry as outlined in the protocol
-fertile women must present a negative pregnancy test
-all fertile patients must use adequate anticonception methods, during and for 6 months after completing the trial
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 58
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion 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.
•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>?Overall survival<br>?Toxicity<br>?Progression free survival and response rate after crossover<br>;Primary end point(s): The fraction of patients alive and without progression after 6 months;Timepoint(s) of evaluation of this end point: Last patient expected to be included by January 31 2013. Last patient reaching the primary end point is 6 months. The study can therefore expectedly be completed and data processed from August 2013

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To evaluate response rate, overall survival, toxicity and progression free survival and response rate after cross-over.;Timepoint(s) of evaluation of this end point: Last patient expected to be included by January 31 2013. Last patient reaching the primary end point is 6 months. The study can therefore expectedly be completed and data processed from August 2013