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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

November 23, 2010
March 20, 2014
November 2010
March 2014   (final data collection date for primary outcome measure)
PFS [ Time Frame: 6 months after last patient included ] [ Designated as safety issue: No ]
Time from treatment start to progression or death.
PFS [ Designated as safety issue: No ]
Time from treatment start to progression or death.
Complete list of historical versions of study NCT01247337 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Response rate. [ Designated as safety issue: No ]
  • Survival [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Intra-hepatic Chemotherapy in Patient With Non-resectable Liver Metastases From Cholangiocarcinoma
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.

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cholangiocarcinoma
  • Drug: Oxaliplatin, capecitabine, gemcitabine, cetuximab
    Intrahepatic oxaliplatin
  • Drug: Oxaliplatin, capecitabine, gemcitabine cetuximab
    Oxaliplatin given intravenous
Experimental: Single arm chemotherapy treatment
Interventions:
  • Drug: Oxaliplatin, capecitabine, gemcitabine, cetuximab
  • Drug: Oxaliplatin, capecitabine, gemcitabine cetuximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
March 2015
March 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01247337
GI 1003
Yes
Dorte Nielsen, Herlev Hospital
Dorte Nielsen
Not Provided
Principal Investigator: Magnus Bergenfeldt, Consultan Department og Gastroenterology
Herlev Hospital
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP