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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. (see Contacts and Locations)
Verified April 2008 by University of Southampton
Sponsor:
Collaborator:
University Hospital Southampton NHS Foundation Trust.
Information provided by (Responsible Party):
University of Southampton
ClinicalTrials.gov Identifier:
NCT00482222
First received: June 4, 2007
Last updated: January 22, 2013
Last verified: April 2008
  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
Biological: cetuximab
Drug: capecitabine
Drug: fluorouracil
Drug: leucovorin calcium
Drug: oxaliplatin
Other: study of socioeconomic and demographic variables
Procedure: adjuvant therapy
Procedure: neoadjuvant therapy
Procedure: quality-of-life assessment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Southampton:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate before surgery as assessed by RECIST criteria [ Time Frame: end of study ] [ Designated as safety issue: No ]
  • Pathological resection status [ Time Frame: end of study ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: end of study ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: end of study ] [ Designated as safety issue: Yes ]
  • Quality of life as assessed by the EQ-5D, EORTC QLQ-C30, and EORTC QLQ-LMC21 [ Time Frame: end of study ] [ Designated as safety issue: No ]
  • Cost effectiveness [ Time Frame: end of study ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: end of study ] [ 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)
Arms Assigned Interventions
Active Comparator: OxMdG / IrMdG chemotherapy
OxMdG / IrMdG chemotherapy for 12 weeks Followed by surgery OxMdG / IrMdG chemotherapy for 12 weeks
Drug: capecitabine Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin Other: study of socioeconomic and demographic variables Procedure: adjuvant therapy Procedure: neoadjuvant therapy Procedure: quality-of-life assessment
Experimental: OxMdG / IrMdG chemotherapy with cetuximab
OxMdG / IrMdG chemotherapy with cetuximab for 12 weeks Followed by Surgery OxMdG / IrMdG chemotherapy with cetuximab for 12 weeks
Biological: cetuximab Drug: capecitabine Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin Other: study of socioeconomic and demographic variables Procedure: adjuvant therapy Procedure: neoadjuvant therapy Procedure: quality-of-life assessment

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Louisa Little 02380795154

Locations
United Kingdom
Basildon University Hospital Recruiting
Basildon, England, United Kingdom, SS16 5NL
Contact: Pauline Leonard, MD    44-1702-435-555      
Basingstoke and North Hampshire NHS Foundation Trust Recruiting
Basingstoke, England, United Kingdom, RG24 9NA
Contact: Charlotte Rees, MD    44-125-631-4793      
Royal Bournemouth Hospital Recruiting
Bournemouth, England, United Kingdom, BH7 7DW
Contact: Tamas Hickish, MD    44-1202-303-626    tamas.hickish@rbch.nhs.uk   
Addenbrooke's Hospital Recruiting
Cambridge, England, United Kingdom, CB2 0QQ
Contact: Pippa Corrie, PhD, FRCP    44-1223-274-401    pippa.corrie@addenbrookes.nhs.uk   
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      
Aintree University Hospital Recruiting
Liverpool, England, United Kingdom, L9 7AL
Contact: Graeme J. Poston, MD    44-151-525-5980    graeme.poston@aintree.nhs.uk   
Royal Liverpool University Hospital Recruiting
Liverpool, England, United Kingdom, L9 7AL
Contact: Paula Ghaneh, MD         
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      
Saint Bartholomew's Hospital Recruiting
London, England, United Kingdom, EC1A 7BE
Contact: Sarah Slater, MD    44-20-7601-8391      
UCL Cancer Institute Recruiting
London, England, United Kingdom, NW3 2PF
Contact: Astrid Mayer, MD    44-207-794-0500    a.mayer@ucl.ac.uk   
Clatterbridge Centre for Oncology Recruiting
Merseyside, England, United Kingdom, CH63 4JY
Contact: David Smith, MD    44-151-334-1155    david.smith@ccotrust.nhs.uk   
St. Mary's Hospital Recruiting
Newport, England, United Kingdom, PO30 5TG
Contact: Christopher Baughan, MD    44-1983-524-081      
Cancer Research Centre at Weston Park Hospital Recruiting
Nottingham, England, United Kingdom, NG5 1PB
Contact: J. Hornbuckle, MD    44-115-969-1169 ext. 47599      
Dorset Cancer Centre Recruiting
Poole Dorset, England, United Kingdom, BH15 2JB
Contact: Tamas Hickish, MD    44-1202-442-532      
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   
Royal Marsden - Surrey Recruiting
Sutton, England, United Kingdom, SM2 5PT
Contact: David Cunningham, MD    44-20-8661-3279    david.cunningham@rmh.nhs.uk   
Southend University Hospital NHS Foundation Trust Recruiting
Westcliff-On-Sea, England, United Kingdom, SS0 0RY
Contact: Pauline Leonard, MD    44-1702-435-555      
Worthing Hospital Recruiting
Worthing, England, United Kingdom, BN11 2DH
Contact: Andrew Webb, MD    44-1903-205-111      
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
University of Southampton
University Hospital Southampton NHS Foundation Trust.
Investigators
Study Chair: John N. Primrose, MD University Hospital Southampton NHS Foundation Trust.
  More Information

Additional Information:
No publications provided

Responsible Party: University of Southampton
ClinicalTrials.gov Identifier: NCT00482222     History of Changes
Other Study ID Numbers: CDR0000549541, USCTU-4351, USCTU-EPOC, EUDRACT-2006-003121-82, ISRCTN22944367, EU-20732
Study First Received: June 4, 2007
Last Updated: January 22, 2013
Health Authority: UK: Medicines and Healthcare producets Regulatory Agency

Keywords provided by University of Southampton:
adenocarcinoma of the colon
stage IV colon cancer
adenocarcinoma of the rectum
stage IV rectal cancer
liver metastases
recurrent colon cancer
recurrent rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Rectal Diseases
Capecitabine
Cetuximab
Fluorouracil
Levoleucovorin
Oxaliplatin
Antidotes
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014