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

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ClinicalTrials.gov Identifier: NCT01247337
Recruitment Status : Unknown
Verified June 2013 by Dorte Nielsen, Herlev Hospital.
Recruitment status was:  Active, not recruiting
First Posted : November 24, 2010
Last Update Posted : March 21, 2014
Sponsor:
Information provided by (Responsible Party):

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

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 ClinicalTrials.gov identifier (NCT number): NCT01247337


Locations
Denmark
Herlev Hospital
Herlev, Denmark, 2730
Sponsors and Collaborators
Dorte Nielsen
Investigators
Principal Investigator: Magnus Bergenfeldt, Consultan Department og Gastroenterology
More Information

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    Key Record Dates
Last Update Posted: March 21, 2014
Last Verified: June 2013

Additional relevant MeSH terms:
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