Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Medical Research Council |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00640081 |
RATIONALE: Drugs used in chemotherapy 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. It is not yet known whether giving combination chemotherapy together with intermittent cetuximab is more effective than combination chemotherapy given together with continuous cetuximab in treating colorectal cancer.
PURPOSE: This randomized phase II trial is studying giving combination chemotherapy together with intermittent cetuximab to see how well it works compared to combination chemotherapy given together with continuous cetuximab as first-line therapy in treating patients with advanced or metastatic colorectal cancer.
Condition | Intervention | Phase |
---|---|---|
Colorectal Cancer |
Biological: cetuximab Drug: capecitabine Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin Other: immunohistochemistry staining method Other: laboratory biomarker analysis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
Official Title: | A Two-Arm Phase II Randomised Trial of Intermittent Chemotherapy Plus Continuous Cetuximab and of Intermittent Chemotherapy Plus Intermittent Cetuximab in First Line Treatment of Metastatic Colorectal Cancer |
Estimated Enrollment: | 136 |
Study Start Date: | July 2007 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of colorectal adenocarcinoma, defined by 1 of the following:
Inoperable metastatic or locoregional disease
Potentially resectable liver metastases allowed provided the following criteria are met:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United Kingdom, England | |
Bradford Royal Infirmary | Recruiting |
Bradford, England, United Kingdom, BD9 6RJ | |
Contact: Contact Person 44-1274-364-273 chris.bradley@bradfordhospitals.nhs.uk | |
Charing Cross Hospital | Recruiting |
London, England, United Kingdom, W6 8RF | |
Contact: Contact Person 44-208-846-1732 charles.lowdell@imperial.nhs.uk | |
Cheltenham General Hospital | Recruiting |
Cheltenham, England, United Kingdom, GL53 7AN | |
Contact: Contact Person 44-845-422-3510 kimbenstead@glos.nhs.uk | |
Churchill Hospital | Recruiting |
Oxford, England, United Kingdom, OX3 7LJ | |
Contact: Contact Person 44-1865-225-681 andrew.weaver@orh.nhs.uk | |
Peterborough Hospitals Trust | Recruiting |
Peterborough, England, United Kingdom, PE3 6DA | |
Contact: Contact Person 4-1733-874-095 Karen.McAdam@pbh-tr.nhs.uk | |
Essex County Hospital | Recruiting |
Colchester, England, United Kingdom, C03 3NB | |
Contact: Contact Person 44-1206-744-438 bruce.sizer@colchesterhospital.nhs.uk | |
Hammersmith Hospital | Recruiting |
London, England, United Kingdom, W12 OHS | |
Contact: Contact Person 44-208-383-3057 wasan@cancer.org.uk | |
Dorset County Hospital | Recruiting |
Dorset, England, United Kingdom, DT1 2JY | |
Contact: Contact Person 44-1305-251-150 rjo2004@btinternet.com | |
Princess Royal Hospital at Hull and East Yorkshire NHS Trust | Recruiting |
Hull, England, United Kingdom, HU8 9HE | |
Contact: Contact Person 44-1482-676-703 anthony.maraveyas@hey.nhs.uk | |
St. Luke's Cancer Centre at Royal Surrey County Hospital | Recruiting |
Guildford, England, United Kingdom, GU2 7XX | |
Contact: Contact Person 44-1483-406-874 gary.middleton@royalsurrey.nhs.uk | |
St. Mary's Hospital | Recruiting |
London, England, United Kingdom, W2 1NY | |
Contact: Contact Person 44-207-886-1132 s.cleator@imperial.ac.uk | |
University Hospital of North Staffordshire | Recruiting |
Stoke-On-Trent, England, United Kingdom, ST4 7LN | |
Contact: Contact Person 44-1782-554-176 fawzi.adab@uhns.nhs.uk | |
United Kingdom, Wales | |
Wrexham Maelor Hospital | Recruiting |
Wrexham, Wales, United Kingdom, LL13 7TD | |
Contact: Contact Person 44-1745-445-161 simon.gollins@cd-tr.wales.nhs.uk | |
Singleton Hospital | Recruiting |
Swansea, Wales, United Kingdom, SA2 8QA | |
Contact: Contact Person 44-1792-285-318 john.wagstaff@swansea-tr.wales.nhs.uk | |
Velindre Cancer Center at Velindre Hospital | Recruiting |
Cardiff, Wales, United Kingdom, CF14 2TL | |
Contact: Contact Person 44-2920-615-888 tim.maughan@velindre-tr.wales.nhs.uk | |
Glan Clwyd Hospital | Recruiting |
Rhyl, Wales, United Kingdom, LL 18 5UJ | |
Contact: Contact Person 44-1745-445-715 simon.gollins@cd-tr.wales.nhs.uk |
Principal Investigator: | Harpreet S. Wasan | Hammersmith Hospital |
Study ID Numbers: | CDR0000589635, MRC-CTU-COIN-B/CR11, EUDRACT:2006-003049-17, ISRCTN38375681, EU-20828, MERCK-MRC-CTU-COIN-B/CR11 |
Study First Received: | March 19, 2008 |
Last Updated: | March 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00640081 History of Changes |
Health Authority: | Unspecified |
adenocarcinoma of the colon stage IV colon cancer adenocarcinoma of the rectum stage IV rectal cancer |
stage III colon cancer stage III rectal cancer recurrent colon cancer recurrent rectal cancer |
Antimetabolites Immunologic Factors Gastrointestinal Diseases Rectal Neoplasms Colonic Diseases Leucovorin Rectal Diseases Oxaliplatin Vitamins Micronutrients Capecitabine Digestive System Neoplasms Vitamin B Complex Cetuximab |
Rectal Neoplasm Trace Elements Intestinal Diseases Immunosuppressive Agents Intestinal Neoplasms Recurrence Calcium, Dietary Rectal Cancer Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Adenocarcinoma Colorectal Neoplasms |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Gastrointestinal Diseases Antineoplastic Agents Colonic Diseases Physiological Effects of Drugs Leucovorin Rectal Diseases Oxaliplatin Neoplasms by Site Vitamins Therapeutic Uses Micronutrients |
Capecitabine Vitamin B Complex Digestive System Neoplasms Growth Substances Cetuximab Intestinal Diseases Immunosuppressive Agents Intestinal Neoplasms Pharmacologic Actions Neoplasms Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Colorectal Neoplasms |