Last updated on January 2013

Combination Chemotherapy With or Without Cetuximab Before and After Surgery in Treating Patients With Resectable Liver Metastases Caused By Colorectal Cancer


Brief description of study

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, leucovorin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving combination chemotherapy together with monoclonal antibodies before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery. It is not yet known whether combination chemotherapy is more effective with or without cetuximab in treating liver metastases caused by colorectal cancer. PURPOSE: This randomized phase III trial is studying combination chemotherapy to compare how well it works when given with or without cetuximab before and after surgery in treating patients with resectable liver metastases caused by colorectal cancer.

Detailed Study Description

OBJECTIVES: Primary - Compare progression-free survival of patients with resectable colorectal liver metastases treated with neoadjuvant and adjuvant combination chemotherapy with vs without cetuximab. Secondary - Compare the overall survival of patients treated with these regimens. - Compare the quality of life of patients treated with these regimens. - Compare the cost effectiveness of these regimens in these patients. OUTLINE: This is a prospective, randomized, multicenter, open-label study. Patients are stratified according to participating center and assigned chemotherapy regimen. Patients are randomized to 1 of 2 treatment arms. - Neoadjuvant therapy: - Arm I: Patients receive 1 of the following chemotherapy regimens: - OxMdG: Patients receive leucovorin calcium IV over 2 hours and oxaliplatin IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. - CAPOX: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. - Arm II: Patients receive 1 of the following regimens: - OxMdG + cetuximab: Patients receive cetuximab IV over 1-2 hours on day 1 and OxMdG chemotherapy as in arm I. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. - CAPOX + cetuximab: Patients receive cetuximab IV over 1-2 hours on days 1, 8, and 15 and CAPOX chemotherapy as in arm I. Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. - Surgery: Beginning 2-6 weeks after completion of chemotherapy, patients in both arms undergo liver resection. - Adjuvant therapy: Beginning 4-8 weeks after completion of surgery, patients receive treatment (OxMdG or CAPOX with or without cetuximab) as in arm I or II of neoadjuvant therapy. - Arm I: Treatment with OxMdG repeats every 2 weeks for up to 6 courses and treatment with CAPOX repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. - Arm II: Treatment with OxMdG + cetuximab repeats every 2 weeks for up to 6 courses and treatment with CAPOX + cetuximab repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every 12 weeks during chemotherapy, at completion of study treatment, every 3 months for 1 year, and then every 6 months thereafter. Cost per life year and per quality-adjusted life year is assessed at baseline, every 12 weeks during treatment, and then at 3, 5, and 10 years. After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years. Peer Reviewed and Funded or Endorsed by Cancer Research UK

Clinical Study Identifier: NCT00482222

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Pauline Leonard, MD

Basildon University Hospital
Basildon, United Kingdom
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Charlotte Rees, MD

Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, United Kingdom
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Tamas Hickish, MD

Royal Bournemouth Hospital
Bournemouth, United Kingdom
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Pippa Corrie, PhD, FRCP

Addenbrooke's Hospital
Cambridge, United Kingdom
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Sharadah Essapen, MD

St. Luke's Cancer Centre at Royal Surrey County Hospital
Guildford, United Kingdom
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Graeme J. Poston, MD

Aintree University Hospital
Liverpool, United Kingdom
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Paula Ghaneh, MD

Royal Liverpool University Hospital
Liverpool, United Kingdom
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Charles P. Lowdell, MD, BSc, ...

Charing Cross Hospital
London, United Kingdom
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David Cunningham, MD

Royal Marsden - London
London, United Kingdom
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Sarah Slater, MD

Saint Bartholomew's Hospital
London, United Kingdom
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Astrid Mayer, MD

UCL Cancer Institute
London, United Kingdom
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David Smith, MD

Clatterbridge Centre for Oncology
Merseyside, United Kingdom
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Christopher Baughan, MD

St. Mary's Hospital
Newport, United Kingdom
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J. Hornbuckle, MD

Cancer Research Centre at Weston Park Hospital
Nottingham, United Kingdom
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Tamas Hickish, MD

Dorset Cancer Centre
Poole Dorset, United Kingdom
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Tim J. Iveson, MD

Salisbury District Hospital
Salisbury, United Kingdom
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John N. Primrose, MD

Southampton General Hospital
Southampton, United Kingdom
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David Cunningham, MD

Royal Marsden - Surrey
Sutton, United Kingdom
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Pauline Leonard, MD

Southend University Hospital NHS Foundation Trust
Westcliff-On-Sea, United Kingdom
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Andrew Webb, MD

Worthing Hospital
Worthing, United Kingdom
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Timothy Maughan, MD

University Hospital of Wales
Cardiff, United Kingdom
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Timothy Maughan, MD

Velindre Cancer Center at Velindre Hospital
Cardiff, United Kingdom
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