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

January 18, 2012 updated by: Copenhagen University Hospital at Herlev

Intrahepatic and Systemic Chemotherapy Together With Antibody to Patients With Non-resectable Liver Metastases From Solid Tumors

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Herlev, Denmark, 2730
        • Recruiting
        • Herlev Hospital
        • Contact:
        • Principal Investigator:
          • Ole Larsen, ph.d., MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • liver metastasis
  • solid tumor

Exclusion Criteria:

  • poor performance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Mitomycin+Gemcitabine
Intrahepatic treatment, where all standard treatments have been used
Drug: Oxaliplatin
oxaliplatin 85 mg/m2 in 10 minutes
Other Names:
  • Gemcitabine
  • Mitomycin c
Drug: Mitomycin + Gemcitabine
Mitomycin 5 mg/m2 Gemcitabine 1000 mg/m2
Other Names:
  • Gemcitabine
  • Mitomycin c

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
tumor response according to RECIST 1.1. Number of patients with CR, PR, SD and PR will be recorded.
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression free survival, adverse events
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Copenhagen University Hospital at Herlev

Investigators

  • Principal Investigator: Finn O Larsen, M.D., Ph.D, Unaffliated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (ANTICIPATED)

July 1, 2015

Study Completion (ANTICIPATED)

July 1, 2016

Study Registration Dates

First Submitted

August 4, 2011

First Submitted That Met QC Criteria

January 12, 2012

First Posted (ESTIMATE)

January 18, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 19, 2012

Last Update Submitted That Met QC Criteria

January 18, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AA-1023

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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