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

• Sponsor: Dorte Nielsen
• Information provided by (Responsible Party): Dorte Nielsen, Herlev Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cholangiocarcinoma	Drug: Oxaliplatin, capecitabine, gemcitabine, cetuximab; Drug: Oxaliplatin, capecitabine, gemcitabine cetuximab	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	100 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	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.
Study Start Date :	November 2010
Estimated Primary Completion Date :	March 2014
Estimated Study Completion Date :	March 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. PFS [ Time Frame: 6 months after last patient included ]
   Time from treatment start to progression or death.

Secondary Outcome Measures :

1. Response rate. [ Time Frame: 6 months after last patient included ]
2. Survival [ Time Frame: 6 months after last patient included ]
3. Toxicity [ Time Frame: 28 days after last treatment of last patient ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Locations

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Denmark
Herlev Hospital
Herlev, Denmark, 2730

Sponsors and Collaborators

Dorte Nielsen

Investigators

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Principal Investigator:	Magnus Bergenfeldt, Consultan	Department og Gastroenterology

More Information

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Responsible Party:	Dorte Nielsen, Responsible Party was entered in the old format as Dorte Nielsen, professor DMSci, Department of Oncology, Herlev Hospital., Herlev Hospital
ClinicalTrials.gov Identifier:	NCT01247337 History of Changes
Other Study ID Numbers:	GI 1003
First Posted:	November 24, 2010
Last Update Posted:	March 21, 2014
Last Verified:	June 2013

Additional relevant MeSH terms:

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Cholangiocarcinoma; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Gemcitabine; Capecitabine; Oxaliplatin; Cetuximab; Antimetabolites, Antineoplastic	Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antiviral Agents; Anti-Infective Agents; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Antineoplastic Agents, Immunological