Intrahepatic Chemotherapy to Patients With Non-resectable Liver Metastases From Solid Tumor
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|ClinicalTrials.gov Identifier: NCT01511146|
Recruitment Status : Unknown
Verified January 2012 by Copenhagen University Hospital at Herlev.
Recruitment status was: Recruiting
First Posted : January 18, 2012
Last Update Posted : January 19, 2012
|Condition or disease||Intervention/treatment||Phase|
|Liver Metastasis||Drug: Oxaliplatin Drug: Mitomycin + Gemcitabine||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intrahepatic and Systemic Chemotherapy Together With Antibody to Patients With Non-resectable Liver Metastases From Solid Tumors|
|Study Start Date :||July 2011|
|Estimated Primary Completion Date :||July 2015|
|Estimated Study Completion Date :||July 2016|
Intrahepatic treatment, where all standard treatments have been used
oxaliplatin 85 mg/m2 in 10 minutes
Drug: Mitomycin + Gemcitabine
Mitomycin 5 mg/m2 Gemcitabine 1000 mg/m2
- tumor response according to RECIST 1.1. Number of patients with CR, PR, SD and PR will be recorded. [ Time Frame: 5 years ]
- Progression free survival, adverse events [ Time Frame: 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01511146
|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|