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Intrahepatic Chemotherapy to Patients With Non-resectable Liver Metastases From Solid Tumor
Conditions
Liver Metastasis
Conditions: official terms
Liver Neoplasms - Neoplasm Metastasis
Conditions: Keywords
oxaliplatin, mitomycin, gemcitabine, intrahepatic, liver metastasis, response in liver metastasis, downsized to operation
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Oxaliplatin
Type: Drug
Name: Mitomycin + Gemcitabine
Type: Drug
Overall Status
Recruiting
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:
- liver metastasis
- solid tumor
Exclusion Criteria:
- poor performance
- liver metastasis
- solid tumor
Exclusion Criteria:
- poor performance
Location
Herlev Hospital
Herlev, Denmark
Status: Recruiting
Contact: Ole Larsen, ph.d., MD - +4538682329 - olelar02@heh.regionh.dk
Start Date
July 2011
Completion Date
July 2016
Sponsors
Copenhagen University Hospital at Herlev
Source
Copenhagen University Hospital at Herlev
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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