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History of Changes for Study: NCT01511146
Intrahepatic Chemotherapy to Patients With Non-resectable Liver Metastases From Solid Tumor
Latest version (submitted January 18, 2012) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 12, 2012 None (earliest Version on record)
2 January 18, 2012 Recruitment Status, Study Status, Outcome Measures and Study Description
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Study NCT01511146
Submitted Date:  January 12, 2012 (v1)

Open or close this module Study Identification
Unique Protocol ID: AA-1023
Brief Title: Intrahepatic Chemotherapy to Patients With Non-resectable Liver Metastases From Solid Tumor
Official Title: Intrahepatic and Systemic Chemotherapy Together With Antibody to Patients With Non-resectable Liver Metastases From Solid Tumors
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2012
Overall Status: Recruiting
Study Start: July 2011
Primary Completion: July 2015 [Anticipated]
Study Completion: July 2016 [Anticipated]
First Submitted: August 4, 2011
First Submitted that
Met QC Criteria:
January 12, 2012
First Posted: January 18, 2012 [Estimate]
Last Update Submitted that
Met QC Criteria:
January 12, 2012
Last Update Posted: January 18, 2012 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Copenhagen University Hospital at Herlev
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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:

  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.
Open or close this module Conditions
Conditions: Liver Metastasis
Keywords: oxaliplatin
mitomycin
gemcitabine
intrahepatic
liver metastasis
response in liver metastasis
downsized to operation
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 100 [Anticipated]
Open or close this module Arms and Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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) ]

Secondary Outcome Measures:
1. Progression free survival, adverse events
[ Time Frame: 5 years (4 years inclusion and 1 to puplication) ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • liver metastasis
  • solid tumor

Exclusion Criteria:

  • poor performance
Open or close this module Contacts/Locations
Study Officials: Finn O Larsen, M.D., Ph.D
Principal Investigator
Unaffliated
Locations: Denmark
Herlev Hospital
[Recruiting]
Herlev, Denmark, 2730
Contact:Contact: Ole Larsen, ph.d., MD +4538682329 olelar02@heh.regionh.dk
Contact:Principal Investigator: Ole Larsen, ph.d., MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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