Randomized phase II trial of combination chemotherapy with panitumumab or bevacizumab for patients with inoperable cholangiocarcinoma without KRAS mutations - GOC-B-P

Phase 1

• Conditions: Inoperable cholangiocarcinoma without KRAS mutations; MedDRA version: 16.1Level: LLTClassification code 10008594Term: Cholangiocarcinoma non-resectableSystem Organ Class: 100000004864

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-09
• Last Update Posted: 17 May 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

•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