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

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. A Phase II Trial.

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.

Study Overview

• Status: Completed
• Conditions: Cholangiocarcinoma
• Intervention / Treatment: Drug: Oxaliplatin, capecitabine, gemcitabine, cetuximab; Drug: Oxaliplatin, capecitabine, gemcitabine cetuximab

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 2

Contacts and Locations

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Herlev Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single arm chemotherapy treatment	Drug: Oxaliplatin, capecitabine, gemcitabine, cetuximab; Intrahepatic oxaliplatin; Drug: Oxaliplatin, capecitabine, gemcitabine cetuximab; Oxaliplatin given intravenous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	Time from treatment start to progression or death.	6 months after last patient included

Secondary Outcome Measures

Outcome Measure	Time Frame
Response rate.	6 months after last patient included
Survival	6 months after last patient included
Toxicity	28 days after last treatment of last patient

Collaborators and Investigators

• Sponsor: Dorte Nielsen
• Investigators: Principal Investigator: Magnus Bergenfeldt, Consultan, Department og Gastroenterology

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2011
• Primary Completion (Actual): February 18, 2016
• Study Completion (Actual): February 18, 2016

Study Registration Dates

• First Submitted: November 23, 2010
• First Submitted That Met QC Criteria: November 23, 2010
• First Posted (Estimate): November 24, 2010

Study Record Updates

• Last Update Posted (Actual): October 5, 2020
• Last Update Submitted That Met QC Criteria: October 1, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Cholangiocarcinoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Gemcitabine; Capecitabine; Oxaliplatin; Cetuximab
• Other Study ID Numbers: GI 1003