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

Phase 2

• Conditions: Liver Metastasis
• Interventions: Drug: Oxaliplatin; Drug: Mitomycin + Gemcitabine

• Registration Number: NCT01511146
• Lead Sponsor: Copenhagen University Hospital at Herlev

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

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 Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-08-04
• Status Verified: 2012-01
• Study First Submitted QC: 2012-01-12
• Study First Posted: 2012-01-18
• Last Update Submitted: 2012-01-18
• Last Update Posted: 2012-01-19
• Primary Completion: 2015-07
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• liver metastasis
• solid tumor

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Exclusion Criteria

• poor performance

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mitomycin+Gemcitabine	Mitomycin + Gemcitabine	Intrahepatic treatment, where all standard treatments have been used
Mitomycin+Gemcitabine	Oxaliplatin	Intrahepatic treatment, where all standard treatments have been used

Primary Outcome Measures

Name	Time	Method
tumor response according to RECIST 1.1. Number of patients with CR, PR, SD and PR will be recorded.	5 years

Secondary Outcome Measures

Name	Time	Method
Progression free survival, adverse events	5 years

Trial Locations

Locations (1)

Herlev Hospital; 🇩🇰 Herlev, Denmark