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

Intrahepatic and Systemic Chemotherapy Together With Antibody to Patients With Non-resectable Liver Metastases From Solid Tumors

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01511146

Enrollment

100

Registered

2012-01-18

Start date

2011-07-31

Completion date

2016-07-31

Last updated

2012-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Metastasis

Keywords

oxaliplatin, mitomycin, gemcitabine, intrahepatic, liver metastasis, response in liver metastasis, downsized to operation

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.

Interventions

DRUGOxaliplatin

oxaliplatin 85 mg/m2 in 10 minutes

DRUGMitomycin + Gemcitabine

Mitomycin 5 mg/m2 Gemcitabine 1000 mg/m2

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* liver metastasis * solid tumor

Exclusion criteria

* poor performance

Design outcomes

Primary

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

Secondary

Measure	Time frame
Progression free survival, adverse events	5 years

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026