To hear about similar clinical trials, please enter your email below
Trial Title:
Intrahepatic Chemotherapy to Patients With Non-resectable Liver Metastases From Solid Tumor
NCT ID:
NCT01511146
Condition:
Liver Metastasis
Conditions: Official terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Gemcitabine
Oxaliplatin
Mitomycins
Mitomycin
Conditions: Keywords:
oxaliplatin
mitomycin
gemcitabine
intrahepatic
liver metastasis
response in liver metastasis
downsized to operation
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
oxaliplatin 85 mg/m2 in 10 minutes
Arm group label:
Mitomycin+Gemcitabine
Other name:
Mitomycin c
Other name:
Gemcitabine
Intervention type:
Drug
Intervention name:
Mitomycin + Gemcitabine
Description:
Mitomycin 5 mg/m2 Gemcitabine 1000 mg/m2
Arm group label:
Mitomycin+Gemcitabine
Other name:
Mitomycin c
Other name:
Gemcitabine
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- liver metastasis
- solid tumor
Exclusion Criteria:
- poor performance
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Herlev Hospital
Address:
City:
Herlev
Zip:
2730
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Ole Larsen, ph.d., MD
Phone:
+4538682329
Email:
olelar02@heh.regionh.dk
Investigator:
Last name:
Ole Larsen, ph.d., MD
Email:
Principal Investigator
Start date:
July 2011
Completion date:
July 2016
Lead sponsor:
Agency:
Copenhagen University Hospital at Herlev
Agency class:
Other
Source:
Copenhagen University Hospital at Herlev
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01511146
