Intrahepatic Chemotherapy to Patients With Non-resectable Liver Metastases From Solid Tumor
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.
Drug: Mitomycin + Gemcitabine
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Intrahepatic and Systemic Chemotherapy Together With Antibody to Patients With Non-resectable Liver Metastases From Solid Tumors|
- tumor response according to RECIST 1.1. Number of patients with CR, PR, SD and PR will be recorded. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Progression free survival, adverse events [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Intrahepatic treatment, where all standard treatments have been used
oxaliplatin 85 mg/m2 in 10 minutes
Other Names:Drug: Mitomycin + Gemcitabine
Mitomycin 5 mg/m2 Gemcitabine 1000 mg/m2
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.
|Herlev, Denmark, 2730|
|Contact: Ole Larsen, ph.d., MD +4538682329 firstname.lastname@example.org|
|Principal Investigator: Ole Larsen, ph.d., MD|
|Principal Investigator:||Finn O Larsen, M.D. , Ph.D||Unaffliated|