Intra-hepatic Chemotherapy in Patient With Non-resectable Liver Metastases From Cholangiocarcinoma

NCT ID: NCT01247337

Last Updated: 2020-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-02
• Study Completion Date: 2016-02-18

Brief Summary

A phase II trial evaluating intra-hepatic chemotherapy with oxaliplatin every second week in combination with systemic gemcitabine and capecitabine in combination with cetuximab in patient with non-resectable liver metastases from cholangiocarcinoma.

Conditions

Cholangiocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single arm chemotherapy treatment

Group Type: EXPERIMENTAL

Oxaliplatin, capecitabine, gemcitabine, cetuximab

Intervention Type: DRUG

Intrahepatic oxaliplatin

Oxaliplatin, capecitabine, gemcitabine cetuximab

Intervention Type: DRUG

Oxaliplatin given intravenous

Interventions

Oxaliplatin, capecitabine, gemcitabine, cetuximab

Intrahepatic oxaliplatin

Intervention Type: DRUG

Oxaliplatin, capecitabine, gemcitabine cetuximab

Oxaliplatin given intravenous

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age > 18 years
• Performance status 0-1; expected survival ≥ 3 months
• Patient with histologically or cytologically adenocarcinoma developed from cells in the gall bladder, extra- or intrahepatic bile ducts or malignant cells consistent with above mentioned and radiologic findings consistent with cholangiocarcinoma
• Liver metastases not suitable for surgery or other local treatment
• Extrahepatic disease should be excluded by PET-CT-scan.
• Prior treatment with chemotherapy or no progression on first line treatment
• Metastases < 70 % of the liver
• neutrophile granulocytes ≥ 1.5 x 109/l og thrombocytes ≥ 100 x 109/l
• bilirubin < 2.0 x UNL (upper normal limit).
• creatinine-clearance ≥ 30 ml/min.
• INR < 2.
• Intrahepatic treatment can be accomplished
• The patients is approved by a multidisciplinary team

Exclusion Criteria

• Cytotoxic or experimental treatment within a 14 days period before start of trial medication
• The patient is not allowed to participate in other clinical trials.
• Any clinical symptoms suggesting peripheral neuropathy grade 2
• Other severe medical conditions
• Severe cardial disease or AMI < 1 year
• Presence of diseases preventing oral therapy
• Patients with uncontrolled infection
• Pregnant or lactating women
• Women capable of childbearing not using a sufficient method of birth control
• Patients not able to understand the treatment or to collaborate
• Prior serious or unsuspected reaction after treatment with fluoropyrimidine
• Known prior hypersensitivity reactions to the agents
• Interstitial pneumonitis or pulmonary fibrosis

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dorte Nielsen

OTHER

Sponsor Role: lead

Responsible Party

Dorte Nielsen

Responsible Party was entered in the old format as Dorte Nielsen, professor DMSci, Department of Oncology, Herlev Hospital.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Magnus Bergenfeldt, Consultan

Role: PRINCIPAL_INVESTIGATOR

Department og Gastroenterology

Locations

Herlev Hospital

Herlev, , Denmark

Countries

Denmark

Other Identifiers

GI 1003

Identifier Type: -

Identifier Source: org_study_id