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

Liver Metastasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01511146
• Other study ID #: AA-1023
• Status: Recruiting
• Phase: Phase 2
• First received: August 4, 2011
• Last updated: January 18, 2012
• Start date: July 2011
• Est. completion date: July 2016

Study information

• Verified date: January 2012
• Source: Copenhagen University Hospital at Herlev
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• liver metastasis

• solid tumor

Exclusion Criteria:

• poor performance

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Metastasis
• Liver Neoplasms
• Neoplasm Metastasis

Intervention

Drug:
• Oxaliplatin
oxaliplatin 85 mg/m2 in 10 minutes
• Mitomycin + Gemcitabine
Mitomycin 5 mg/m2 Gemcitabine 1000 mg/m2

Locations

Country	Name	City	State
Denmark	Herlev Hospital	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Copenhagen University Hospital at Herlev

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tumor response according to RECIST 1.1. Number of patients with CR, PR, SD and PR will be recorded.		5 years	No
Secondary	Progression free survival, adverse events		5 years	No