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Trial record 1 of 1 for:    NCT01247337
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Intra-hepatic Chemotherapy in Patient With Non-resectable Liver Metastases From Cholangiocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01247337
Recruitment Status : Completed
First Posted : November 24, 2010
Last Update Posted : October 5, 2020
Information provided by (Responsible Party):
Dorte Nielsen, Herlev Hospital

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: N/A
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.
Actual Study Start Date : February 2, 2011
Actual Primary Completion Date : February 18, 2016
Actual Study Completion Date : February 18, 2016

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

Drug: Oxaliplatin, capecitabine, gemcitabine cetuximab
Oxaliplatin given intravenous

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 ]

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01247337

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Herlev Hospital
Herlev, Denmark, 2730
Sponsors and Collaborators
Dorte Nielsen
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Principal Investigator: Magnus Bergenfeldt, Consultan Department og Gastroenterology
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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 Identifier: NCT01247337    
Other Study ID Numbers: GI 1003
First Posted: November 24, 2010    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: October 2020
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
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