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

Study Overview
=================
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.

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

Conditions
-----------------
Liver Metastasis

Intervention / Treatment
-----------------
* Drug: Oxaliplatin
* Drug: Mitomycin + Gemcitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: liver metastasis solid tumor Exclusion Criteria: poor performance

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mitomycin+Gemcitabine<br>Intrahepatic treatment, where all standard treatments have been used | Drug: Oxaliplatin<br>* oxaliplatin 85 mg/m2 in 10 minutes<br>* Other names: Gemcitabine;Drug: Mitomycin + Gemcitabine<br>* Mitomycin 5 mg/m2 Gemcitabine 1000 mg/m2<br>* Other names: Gemcitabine;|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival, adverse events |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oxaliplatin, mitomycin, gemcitabine, intrahepatic, liver metastasis, response in liver metastasis, downsized to operation