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

This study is currently recruiting participants.
Verified January 2012 by Copenhagen University Hospital at Herlev
Sponsor:
Information provided by (Responsible Party):
Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier:
NCT01511146
First received: August 4, 2011
Last updated: January 18, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Liver Metastasis
 Drug: Oxaliplatin
Drug: Mitomycin + Gemcitabine
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intrahepatic and Systemic Chemotherapy Together With Antibody to Patients With Non-resectable Liver Metastases From Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Copenhagen University Hospital at Herlev:

Primary Outcome Measures:
  • tumor response according to RECIST 1.1. Number of patients with CR, PR, SD and PR will be recorded. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival, adverse events [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2011
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mitomycin+Gemcitabine
Intrahepatic treatment, where all standard treatments have been used
 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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • liver metastasis
  • solid tumor

Exclusion Criteria:

  • poor performance
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01511146

Locations
Denmark
Herlev Hospital Recruiting
Herlev, Denmark, 2730
Contact: Ole Larsen, ph.d., MD     +4538682329     olelar02@heh.regionh.dk    
Principal Investigator: Ole Larsen, ph.d., MD            
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
Investigators
Principal Investigator: Finn O Larsen, M.D. , Ph.D Unaffliated
  More Information

No publications provided

Responsible Party: Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier: NCT01511146     History of Changes
Other Study ID Numbers: AA-1023
Study First Received: August 4, 2011
Last Updated: January 18, 2012
Health Authority: Denmark: Ethics Committee

Keywords provided by Copenhagen University Hospital at Herlev:
oxaliplatin
mitomycin
gemcitabine
intrahepatic
 liver metastasis
response in liver metastasis
downsized to operation

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Mitomycins
Mitomycin
Gemcitabine
Oxaliplatin
Antibiotics, Antineoplastic
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Alkylating Agents
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on May 16, 2013