Study Comparing Radio Frequency Ablation Plus Chemotherapy and Chemotherapy Alone in Patients With Secondary Liver Metastases

• Status: Withdrawn
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether patients treated with Radiofrequency Ablation (RFA) in conjunction with chemotherapy have a better overall survival rate than patients treated with chemotherapy alone.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Scientific Corporation
• Treatments: Cetuximab; Irinotecan; Oxaliplatin

Criteria

Inclusion Criteria:

All subjects must meet the following criteria:

• Subject must have incurable metastatic colorectal cancer with metastatic disease to the liver

• Subject must have extrahepatic metastatic disease, as confirmed by radiographic evidence or surgical/other documentation that cannot be treated by surgery or image guided therapy to an endpoint of no evidence of residual disease by imaging criteria

• Subject has received and, in the opinion of the treating physician, progressed through at least one prior chemotherapy regimen for metastatic disease, or has developed recurrent disease on or within 6 months of completing adjuvant therapy

• At least 50% of the total tumor burden is in the liver, as determined by the treating investigator, and prior to any study specified intervention (resection or ablation).

• Subject must have no more than 10 hepatic tumors remaining after surgical resection, with no tumor exhibiting a unidimensional size greater than 5cm

• Subject is medically eligible to receive RFA, as determined by the treating investigator

• Subject is naïve to, and medically eligible (as defined by the treating investigator) to receive, at least one of the following:

• an oxaliplatin containing regimen

• an irinotecan containing regimen

• an anti-EGFR monoclonal antibody-containing regimen (subject must be naïve to both cetuximab and panitumumab)

• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1

• Age > 18 years

• Subject life expectancy > 3 months

• International Normalized Ratio (INR) < 2.0

• Platelets > 100 x103/mm3

• Total Bilirubin <1.5mg/dl

• Creatinine level < 2.0 mg/dl

• Must sign an Informed Consent form

Exclusion Criteria:

All subjects who meet any of the following criteria will not be enrolled into the study:

• Subjects's extrahepatic disease is amenable to curative surgical or image guided therapy

• Subject has known brain metastases

• Uncorrectable coagulopathy

• Subject is pregnant, nursing, or wishes to become pregnant during the study

• Other serious medical condition(s) (e.g. uncontrolled infection, uncontrolled cardiac disease) that, in the opinion of the treating investigator, would preclude study treatment or impact survival.

• Current or planned treatment with any experimental chemotherapy or biological agents