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

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2014

Interventions

  • Drug: Oxaliplatin, capecitabine, gemcitabine, cetuximab
    • Intrahepatic oxaliplatin
  • Drug: Oxaliplatin, capecitabine, gemcitabine cetuximab
    • Oxaliplatin given intravenous

Arms, Groups and Cohorts

  • Experimental: Single arm chemotherapy treatment

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Dorte Nielsen
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Dorte Nielsen, Responsible Party was entered in the old format as Dorte Nielsen, professor DMSci, Department of Oncology, Herlev Hospital. – Herlev Hospital
  • Overall Official(s)
    • Magnus Bergenfeldt, Consultan, Principal Investigator, Department og Gastroenterology

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