We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01511146
Previous Study | Return to List | Next Study

Intrahepatic Chemotherapy to Patients With Non-resectable Liver Metastases From Solid Tumor

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.
 
ClinicalTrials.gov Identifier: NCT01511146
Recruitment Status : Unknown
Verified January 2012 by Copenhagen University Hospital at Herlev.
Recruitment status was:  Recruiting
First Posted : January 18, 2012
Last Update Posted : January 19, 2012
Sponsor:
Information provided by (Responsible Party):
Copenhagen University Hospital at Herlev

Tracking Information
First Submitted Date  ICMJE August 4, 2011
First Posted Date  ICMJE January 18, 2012
Last Update Posted Date January 19, 2012
Study Start Date  ICMJE July 2011
Estimated Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2012)
tumor response according to RECIST 1.1. Number of patients with CR, PR, SD and PR will be recorded. [ Time Frame: 5 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 12, 2012)
tumor response according to RECIST 1.1. Number of patients with CR, PR, SD and PR will be recorded. [ Time Frame: 5 years (4 years inclusion and 1 to puplication) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2012)
Progression free survival, adverse events [ Time Frame: 5 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2012)
Progression free survival, adverse events [ Time Frame: 5 years (4 years inclusion and 1 to puplication) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intrahepatic Chemotherapy to Patients With Non-resectable Liver Metastases From Solid Tumor
Official Title  ICMJE Intrahepatic and Systemic Chemotherapy Together With Antibody to Patients With Non-resectable Liver Metastases From Solid Tumors
Brief Summary The purpose of this study is to see if treatment with intrahepatic chemotherapy is a good options in patients with liver metastases. If the patients have colorectal cancer and never had got chemotherapy the investigators will use oxaliplatin together with capecitabine. If the patient is K-RAS wild type the investigators will add cetuximab. In patients who had received oxaliplatin or in patients with other cancers the investigators will use mitomycin and gemcitabine together with capecitabine.
Detailed Description

Two regiment are used: N.B. The two regiments will be reported separately

  1. Mitomycin + Gemcitabine intrahepatic together with Capecitabine. This treatment can be offered patients with solid tumors where all standard treatments have been used. The patients are not allowed to have extrahepatic disease. The purpose of the treatment are to prolonged life.
  2. FOLFOX where oxaliplatin is given intrahepatic each second time. The treatment are only for patients with colorectal cancer where cure is possible but resection straight ahead is not possible. The patients are allowed to have their colorectal cancer in situ for operation latter on. If the patients are KRAS Wild-type, cetuximab are added.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Liver Metastasis
Intervention  ICMJE
  • Drug: Oxaliplatin
    oxaliplatin 85 mg/m2 in 10 minutes
    Other Names:
    • Mitomycin c
    • Gemcitabine
  • Drug: Mitomycin + Gemcitabine
    Mitomycin 5 mg/m2 Gemcitabine 1000 mg/m2
    Other Names:
    • Mitomycin c
    • Gemcitabine
Study Arms  ICMJE Experimental: Mitomycin+Gemcitabine
Intrahepatic treatment, where all standard treatments have been used
Interventions:
  • Drug: Oxaliplatin
  • Drug: Mitomycin + Gemcitabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 12, 2012)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2016
Estimated Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • liver metastasis
  • solid tumor

Exclusion Criteria:

  • poor performance
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01511146
Other Study ID Numbers  ICMJE AA-1023
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Copenhagen University Hospital at Herlev
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Copenhagen University Hospital at Herlev
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Finn O Larsen, M.D., Ph.D Unaffliated
PRS Account Copenhagen University Hospital at Herlev
Verification Date January 2012

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