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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dorte Nielsen, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01247337
First received: November 23, 2010
Last updated: March 20, 2014
Last verified: June 2013
  Purpose

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 Intervention Phase
Cholangiocarcinoma
Drug: Oxaliplatin, capecitabine, gemcitabine, cetuximab
Drug: Oxaliplatin, capecitabine, gemcitabine cetuximab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • PFS [ Time Frame: 6 months after last patient included ] [ Designated as safety issue: No ]
    Time from treatment start to progression or death.


Secondary Outcome Measures:
  • Response rate. [ Time Frame: 6 months after last patient included ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: 6 months after last patient included ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: 28 days after last treatment of last patient ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: November 2010
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single arm chemotherapy treatment Drug: Oxaliplatin, capecitabine, gemcitabine, cetuximab
Intrahepatic oxaliplatin
Drug: Oxaliplatin, capecitabine, gemcitabine cetuximab
Oxaliplatin given intravenous

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01247337

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

No publications provided

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
Study First Received: November 23, 2010
Last Updated: March 20, 2014
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Neoplasm Metastasis
Cholangiocarcinoma
Neoplastic Processes
Neoplasms
Pathologic Processes
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gemcitabine
Capecitabine
Fluorouracil
Oxaliplatin
Cetuximab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on April 14, 2014