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

Phase 2

Completed

• Conditions: Cholangiocarcinoma
• Interventions: Drug: Oxaliplatin, capecitabine, gemcitabine, cetuximab; Drug: Oxaliplatin, capecitabine, gemcitabine cetuximab

• Registration Number: NCT01247337
• Lead Sponsor: Dorte Nielsen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-23
• Study First Submitted QC: 2010-11-23
• Study First Posted: 2010-11-24
• Study Start: 2011-02-02
• Primary Completion: 2016-02-18
• Study Completion: 2016-02-18
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-01
• Last Update Posted: 2020-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Informed consent

• 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

• Other current or prior malignant disease except adequately treated and cured carcinoma in situ of the cervix or squamous cell carcinoma of the skin.

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm chemotherapy treatment	Oxaliplatin, capecitabine, gemcitabine cetuximab	-
Single arm chemotherapy treatment	Oxaliplatin, capecitabine, gemcitabine, cetuximab	-

Primary Outcome Measures

Name	Time	Method
PFS	6 months after last patient included	Time from treatment start to progression or death.

Secondary Outcome Measures

Name	Time	Method
Response rate.	6 months after last patient included
Toxicity	28 days after last treatment of last patient
Survival	6 months after last patient included

Trial Locations

Locations (1)

Herlev Hospital; 🇩🇰 Herlev, Denmark