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

Primary Purpose

Liver Metastasis

Status
Unknown status
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Oxaliplatin
Mitomycin + Gemcitabine
Sponsored by
Copenhagen University Hospital at Herlev
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Metastasis focused on measuring oxaliplatin, mitomycin, gemcitabine, intrahepatic, liver metastasis, response in liver metastasis, downsized to operation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • liver metastasis
  • solid tumor

Exclusion Criteria:

  • poor performance

Sites / Locations

  • Herlev HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mitomycin+Gemcitabine

Arm Description

Intrahepatic treatment, where all standard treatments have been used

Outcomes

Primary Outcome Measures

tumor response according to RECIST 1.1. Number of patients with CR, PR, SD and PR will be recorded.

Secondary Outcome Measures

Progression free survival, adverse events

Full Information

First Posted
August 4, 2011
Last Updated
January 18, 2012
Sponsor
Copenhagen University Hospital at Herlev
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1. Study Identification

Unique Protocol Identification Number
NCT01511146
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Copenhagen University Hospital at Herlev

4. Oversight

Data Monitoring Committee
Yes

5. 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: N.B. The two regiments will be reported separately 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Metastasis
Keywords
oxaliplatin, mitomycin, gemcitabine, intrahepatic, liver metastasis, response in liver metastasis, downsized to operation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mitomycin+Gemcitabine
Arm Type
Experimental
Arm Description
Intrahepatic treatment, where all standard treatments have been used
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
Mitomycin c, Gemcitabine
Intervention Description
oxaliplatin 85 mg/m2 in 10 minutes
Intervention Type
Drug
Intervention Name(s)
Mitomycin + Gemcitabine
Other Intervention Name(s)
Mitomycin c, Gemcitabine
Intervention Description
Mitomycin 5 mg/m2 Gemcitabine 1000 mg/m2
Primary Outcome Measure Information:
Title
tumor response according to RECIST 1.1. Number of patients with CR, PR, SD and PR will be recorded.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Progression free survival, adverse events
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: liver metastasis solid tumor Exclusion Criteria: poor performance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Finn O Larsen, M.D., Ph.D
Organizational Affiliation
Unaffliated
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herlev Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ole Larsen, ph.d., MD
Phone
+4538682329
Email
olelar02@heh.regionh.dk
First Name & Middle Initial & Last Name & Degree
Ole Larsen, ph.d., MD

12. IPD Sharing Statement

Learn more about this trial

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

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