Chemotherapy and Bevacizumab With or Without Radiofrequency Ablation in Treating Unresectable Liver Metastases in Patients With Colorectal Cancer
Colorectal Cancer, Metastatic Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring liver metastases, stage IV colon cancer, stage IV rectal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Unresectable liver metastases secondary to colorectal adenocarcinoma, including: Metastases that cannot be radically resected due to size, location, or number of deposits Metastases invading right and left branches of hepatic artery or portal vein Metastases extended to the 3 main hepatic veins No detectable extra-hepatic disease Fewer than 10 metastatic deposits on liver Total metastatic involvement of liver no more than 50% Adequate treatment of all metastatic lesions deemed possible either by radiofrequency interstitial ablation (RFA) alone or by a combination of resection of resectable lesions and RFA of the remaining unresectable lesions Maximum diameter of 4 cm for lesions to be treated with RFA No maximum diameter of lesions to be resected as long as negative resection margins are obtainable If synchronous liver metastases, must have undergone prior resection of primary tumor PATIENT CHARACTERISTICS: Age 18 to 80 Performance status WHO 0-1 Life expectancy Not specified Hematopoietic Absolute neutrophil count greater than 1,500/mm^3 Platelet count greater than 100,000/mm^3 No bleeding disorder or coagulopathy or need for full-dose anticoagulation Hepatic Bilirubin less than 3 times upper limit of normal (ULN) Alkaline phosphatase less than 3 times ULN Renal Creatinine less than 2 times ULN Protein < 0.5 g/24 hr urine collection if proteinuria positive by dipstick Cardiovascular No uncontrolled congestive heart failure No uncontrolled angina pectoris No uncontrolled hypertension No uncontrolled arrhythmia No myocardial infarction within the past 12 months No cerebrovascular accident or transient ischemic attack within the past 6 months Other Not pregnant or nursing Fertile patients must use effective contraception No greater than grade 1 peripheral neuropathy No significant neurologic or psychiatric disorder No active infection No contraindication to the use of fluorouracil, leucovorin calcium, oxaliplatin, or bevacizumab No other malignancy within the past 10 years except nonmelanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy except for metastatic disease confined to the liver Prior fluorouracil, leucovorin calcium, and oxaliplatin allowed if administered for at least 3 courses (2 weeks each) but no longer than 3 months with at least stabilization of disease achieved Prior adjuvant chemotherapy for primary cancer allowed except for patients who received oxaliplatin and have been diagnosed with metastatic disease within 12 months after completion of adjuvant treatment Endocrine therapy Not specified Radiotherapy Not specified Surgery More than 28 days since major surgery or open biopsy past 28 days More than 28 days since significant traumatic injury Other No other concurrent investigational treatment No other concurrent anticancer therapy
Sites / Locations
- Allgemeines Krankenhaus - Universitatskliniken
- Ziekenhuis Netwerk Antwerpen Middelheim
- Institut Jules Bordet
- Universitair Ziekenhuis Antwerpen
- Universitair Ziekenhuis Gent
- Clinique Universitaire De Mont-Godinne
- National Cancer Institute - Cairo
- Centre Hospitalier Regional et Universitaire d'Angers
- Centre Hospitalier Universitaire Ambroise Pare - Boulogne
- Hopital Universitaire Hautepierre
- Centre Alexis Vautrin
- Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch
- Kliniken Essen - Mitte
- Klinikum der J.W. Goethe Universitaet
- Staedtische Kliniken Frankfurt am Main - Hoechst
- Klinikum der Universitaet Regensburg
- National Institute of Oncology
- Azienda Ospedaliera S. Camillo-Forlanini
- Jeroen Bosch Ziekenhuis
- Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
- Amphia Ziekenhuis - locatie Langendijk
- Medisch Spectrum Twente
- Atrium Medical Centre - Heerlen
- Medisch Centrum Leeuwarden - Zuid
- Academisch Ziekenhuis Maastricht
- Universitair Medisch Centrum St. Radboud - Nijmegen
- University Medical Center Utrecht
- Maxima Medisch Centrum - Veldhoven
- Sahlgrenska University Hospital at Gothenburg University
- Karolinska University Hospital - Huddinge
- Uppsala University Hospital
- Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
- Bristol Haematology and Oncology Centre
- Leicester General Hospital
- Royal Liverpool University Hospital
- Cancer Research UK and University College London Cancer Trials Centre
- University College of London Hospitals
- Manchester Royal Infirmary
- Clatterbridge Centre for Oncology NHS Trust
- Churchill Hospital
- Royal South Hants Hospital
- Velindre Cancer Center at Velindre Hospital
- Glan Clywd District General Hospital