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

NCT ID: NCT01511146

Last Updated: 2012-01-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2016-07-31

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.

Conditions

Liver Metastasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mitomycin+Gemcitabine

Intrahepatic treatment, where all standard treatments have been used

Group Type: EXPERIMENTAL

Oxaliplatin

Intervention Type: DRUG

oxaliplatin 85 mg/m2 in 10 minutes

Mitomycin + Gemcitabine

Intervention Type: DRUG

Mitomycin 5 mg/m2 Gemcitabine 1000 mg/m2

Interventions

Oxaliplatin

oxaliplatin 85 mg/m2 in 10 minutes

Intervention Type: DRUG

Mitomycin + Gemcitabine

Mitomycin 5 mg/m2 Gemcitabine 1000 mg/m2

Intervention Type: DRUG

Other Intervention Names

Mitomycin c; Gemcitabine; Mitomycin c; Gemcitabine

Eligibility Criteria

Inclusion Criteria

• liver metastasis
• solid tumor

Exclusion Criteria

• poor performance

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Copenhagen University Hospital at Herlev

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Finn O Larsen, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Unaffliated

Locations

Herlev Hospital

Herlev, , Denmark

Site Status: RECRUITING

Countries

Denmark

Facility Contacts

Ole Larsen, ph.d., MD

Role: primary

olelar02@heh.regionh.dk

+4538682329

Other Identifiers

AA-1023

Identifier Type: -

Identifier Source: org_study_id