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

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), April 2008

Sponsored by: Southampton General Hospital
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00482222
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Metastatic Cancer
Drug: capecitabine
Drug: cetuximab
Drug: fluorouracil
Drug: leucovorin calcium
Drug: oxaliplatin
Procedure: adjuvant therapy
Procedure: neoadjuvant therapy
Procedure: quality-of-life assessment
Procedure: study of socioeconomic and demographic variables
Phase III

MedlinePlus related topics:   Cancer    Colorectal Cancer   

ChemIDplus related topics:   Leucovorin Calcium    Citrovorum factor    Folinic acid calcium salt pentahydrate    Leucovorin    Capecitabine    Fluorouracil    Oxaliplatin    Calcium gluconate    Cetuximab   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label
Official Title:   A Prospective Randomised Open Label Trial of Oxaliplatin/Fluoropyrimidine Versus Oxaliplatin/Fluoropyrimidine Plus Cetuximab Pre and Post Operatively in Patients With Resectable Colorectal Liver Metastasis Requiring Chemotherapy

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate before surgery as assessed by RECIST criteria [ Designated as safety issue: No ]
  • Pathological resection status [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Quality of life as assessed by the EQ-5D, EORTC QLQ-C30, and EORTC QLQ-LMC21 [ Designated as safety issue: No ]
  • Cost effectiveness [ Designated as safety issue: No ]
  • Safety [ Designated as safety issue: Yes ]

Estimated Enrollment:   340
Study Start Date:   February 2007
Estimated Primary Completion Date:   December 2014 (Final data collection date for primary outcome measure)

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Histologically* or radiologically confirmed primary adenocarcinoma of the colon or rectum

    • Advanced and/or metastatic disease NOTE: *Liver metastases should not be biopsied
  • Must have potentially resectable liver metastases present, as defined by any of the following:

    • Metachronous metastases AND complete resection of the primary tumor without gross or microscopic evidence of residual disease (R0)
    • Synchronous metastases AND R0 resection of the primary tumor > 1 month before study entry
    • Synchronous metastases with sufficient evidence (e.g., by CT scan or diagnostic laparoscopy) that both the primary tumor and the liver metastases can be completely resected during the same procedure and resection of primary tumor can be delayed for 3-4 months
    • Suboptimally resectable disease (i.e., potentially resectable disease with compromise of the resection margins)
  • No detectable extrahepatic tumor that cannot be completely resected
  • Unidimensionally measurable disease
  • No brain metastases

PATIENT CHARACTERISTICS:

  • WHO performance status 0-2
  • WBC ≥ 4,000/mm³
  • ANC ≥ 1,500/mm³
  • Platelet count > 150,000/mm³
  • Bilirubin ≤ 1.25 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 5 times ULN
  • AST or ALT ≤ 3 times ULN
  • Creatinine clearance > 50 mL/min OR glomerular filtration rate > 50 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
  • No psychiatric or neurological condition that would preclude study compliance
  • No partial or complete bowel obstruction
  • No preexisting neuropathy > grade 1
  • No other prior or concurrent malignant disease that, in the opinion of the investigator, would preclude study treatment
  • No concurrent severe uncontrolled medical illness (including poorly-controlled angina or myocardial infarction within the past 3 months) that would preclude study treatment
  • No known hypersensitivity reaction to any of the components of the study drugs

PRIOR CONCURRENT THERAPY:

  • No prior systemic chemotherapy for metastatic disease
  • More than 6 months since prior adjuvant chemotherapy comprising fluorouracil, leucovorin calcium, capecitabine, or irinotecan hydrochloride
  • More than 1 month since prior rectal chemoradiotherapy comprising fluorouracil and leucovorin calcium
  • No concurrent contraindicated medication
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00482222

Locations
United Kingdom, England
Addenbrooke's Hospital     Recruiting
      Cambridge, England, United Kingdom, CB2 0QQ
      Contact: Pippa Corrie, PhD, FRCP     44-1223-274-401     pippa.corrie@addenbrookes.nhs.uk    
Aintree University Hospital     Recruiting
      Liverpool, England, United Kingdom, L9 7AL
      Contact: Graeme J. Poston, MD     44-151-525-5980     graeme.poston@aintree.nhs.uk    
Basildon University Hospital     Recruiting
      Basildon, England, United Kingdom, SS16 5NL
      Contact: Pauline Leonard, MD     44-1702-435-555        
Cancer Research Centre at Weston Park Hospital     Recruiting
      Nottingham, England, United Kingdom, NG5 1PB
      Contact: J. Hornbuckle, MD     44-115-969-1169 ext. 47599        
Charing Cross Hospital     Recruiting
      London, England, United Kingdom, W6 8RF
      Contact: Charles P. Lowdell, MD, BSc, MBBS, FRCP, FRCR     44-208-383-0576     charles.lowdell@imperial.nhs.uk    
Royal Marsden - London     Recruiting
      London, England, United Kingdom, SW3 6JJ
      Contact: David Cunningham, MD     44-20-8661-3156        
North Hampshire Hospital     Recruiting
      Basingstoke, England, United Kingdom, RG24 9NA
      Contact: Charlotte Rees, MD     44-125-631-4793        
Poole Hospital NHS Trust     Recruiting
      Poole Dorset, England, United Kingdom, BH15 2JB
      Contact: Tamas Hickish, MD     44-1202-448-263        
Royal Bournemouth Hospital NHS Trust     Recruiting
      Bournemouth, England, United Kingdom, BH7 7DW
      Contact: Tamas Hickish, MD     44-1202-303-626     tamas.hickish@rbch.nhs.uk    
Royal Liverpool University Hospital     Recruiting
      Liverpool, England, United Kingdom, L9 7AL
      Contact: Paula Ghaneh, MD     Not Available        
Clatterbridge Centre for Oncology     Recruiting
      Merseyside, England, United Kingdom, CH63 4JY
      Contact: David Smith, MD     44-151-334-1155     david.smith@ccotrust.nhs.uk    
Royal Marsden - Surrey     Recruiting
      Sutton, England, United Kingdom, SM2 5PT
      Contact: David Cunningham, MD     44-20-8661-3279     david.cunningham@rmh.nhs.uk    
Saint Bartholomew's Hospital     Recruiting
      London, England, United Kingdom, EC1A 7BE
      Contact: Sarah Slater, MD     44-20-7601-8391        
Salisbury District Hospital     Recruiting
      Salisbury, England, United Kingdom, SP2 8BJ
      Contact: Tim J. Iveson, MD     44-1722-336-262 ext. 4688        
Southampton General Hospital     Recruiting
      Southampton, England, United Kingdom, SO16 6YD
      Contact: John N. Primrose, MD     44-23-8079-6144     j.n.primrose@soton.ac.uk    
Southend University Hospital NHS Foundation Trust     Recruiting
      Westcliff-On-Sea, England, United Kingdom, SS0 0RY
      Contact: Pauline Leonard, MD     44-1702-435-555        
St. Luke's Cancer Centre at Royal Surrey County Hospital     Recruiting
      Guildford, England, United Kingdom, GU2 7XX
      Contact: Sharadah Essapen, MD     44-1483-571-122        
St. Mary's Hospital     Recruiting
      Newport, England, United Kingdom, PO30 5TG
      Contact: Christopher Baughan, MD     44-1983-524-081        
UCL Cancer Institute     Recruiting
      London, England, United Kingdom, NW3 2PF
      Contact: Astrid Mayer, MD     44-207-794-0500     a.mayer@ucl.ac.uk    
Worthing Hospital     Recruiting
      Worthing, England, United Kingdom, BN11 2DH
      Contact: Andrew Webb, MD     44-1903-205-111        
United Kingdom, Wales
University Hospital of Wales     Recruiting
      Cardiff, Wales, United Kingdom, CF14 4XW
      Contact: Timothy Maughan, MD     44-2920-316-904        
Velindre Cancer Center at Velindre Hospital     Recruiting
      Cardiff, Wales, United Kingdom, CF14 2TL
      Contact: Timothy Maughan, MD     44-2920-316-904        

Sponsors and Collaborators
Southampton General Hospital

Investigators
Study Chair:     John N. Primrose, MD     Southampton General Hospital    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000549541, USCTU-4351, USCTU-EPOC, EUDRACT-2006-003121-82, ISRCTN22944367, EU-20732
First Received:   June 4, 2007
Last Updated:   August 13, 2008
ClinicalTrials.gov Identifier:   NCT00482222
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the colon  
stage IV colon cancer  
adenocarcinoma of the rectum  
stage IV rectal cancer  
liver metastases
recurrent colon cancer
recurrent rectal cancer

Study placed in the following topic categories:
Capecitabine
Digestive System Neoplasms
Gastrointestinal Diseases
Cetuximab
Colonic Diseases
Leucovorin
Intestinal Diseases
Rectal Diseases
Recurrence
Intestinal Neoplasms
Oxaliplatin
Digestive System Diseases
Fluorouracil
Neoplasm Metastasis
Gastrointestinal Neoplasms
Adenocarcinoma
Rectal cancer
Colorectal Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Vitamin B Complex
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplastic Processes
Neoplasms by Site
Pathologic Processes
Vitamins
Therapeutic Uses
Micronutrients

ClinicalTrials.gov processed this record on October 17, 2008




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