GW572016, An Oral Drug For Colorectal Cancer Patients Having Prior Therapy With 5-FU Plus CPT-11 And/Or Oxaliplatin
NCT ID: NCT00044343
Last Updated: 2014-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
80 participants
INTERVENTIONAL
2002-09-30
2003-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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lapatinib
Eligibility Criteria
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Inclusion Criteria
* Refractory Stage IV metastatic colorectal cancer.
* Received at least 2 cycles of first-line therapy with intravenous 5-FU (5-fluorouracil) in combination with CPT-11 (irinotecan) and/or oxaliplatin.
* No more than one prior therapy.
* Tumor tissue available for testing.
* 4 weeks since first-line cancer regimen.
* Able to swallow and retain oral medication.
* Cardiac ejection fraction within the institutional range of normal as measured by MUGA (Multiple Gated Acquisition Scan).
* Adequate kidney and liver function.
* Adequate bone marrow function.
Exclusion Criteria
* Conditions that would affect absorption of an oral drug
* First-line regimen did not include 5-fluorouracil with irinotecan and/or oxaliplatin.
* Serious medical or psychiatric disorder that would interfere with the patient''s safety or informed consent.
* Severe cardiovascular disease or cardiac (heart) disease requiring a device.
* Active infection.
* Brain metastases.
* Concurrent cancer therapy or investigational therapy.
* Use of oral or intravenous steroids.
* Unresolved or unstable, serious toxicity from prior therapy.
* Prior therapy with an EGFR (Endothelial Growth Factor Receptor) and/or erbB-2 inhibitor.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trial, MD
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Clinical Trials Call Center
Los Angeles, California, United States
GSK Clinical Trials Call Center
Poway, California, United States
GSK Clinical Trials Call Center
Torrington, Connecticut, United States
GSK Clinical Trials Call Center
Boca Raton, Florida, United States
GSK Clinical Trials Call Center
Fort Lauderdale, Florida, United States
GSK Clinical Trials Call Center
Fort Myers, Florida, United States
GSK Clinical Trials Call Center
Miami, Florida, United States
GSK Clinical Trials Call Center
Sarasota, Florida, United States
GSK Clinical Trials Call Center
Atlanta, Georgia, United States
GSK Clinical Trials Call Center
Marietta, Georgia, United States
GSK Clinical Trials Call Center
Terre Haute, Indiana, United States
GSK Clinical Trials Call Center
Des Moines, Iowa, United States
GSK Clinical Trials Call Center
Lafayette, Louisiana, United States
GSK Clinical Trials Call Center
New Orleans, Louisiana, United States
GSK Clinical Trials Call Center
Rockville, Maryland, United States
GSK Clinical Trials Call Center
Wellesley, Massachusetts, United States
GSK Clinical Trials Call Center
Saint Charles, Missouri, United States
GSK Clinical Trials Call Center
Saint Joseph, Missouri, United States
GSK Clinical Trials Call Center
St Louis, Missouri, United States
GSK Clinical Trials Call Center
Billings, Montana, United States
GSK Clinical Trials Call Center
Great Falls, Montana, United States
GSK Clinical Trials Call Center
Omaha, Nebraska, United States
GSK Clinical Trials Call Center
Hooksett, New Hampshire, United States
GSK Clinical Trials Call Center
Morristown, New Jersey, United States
GSK Clinical Trials Call Center
Summit, New Jersey, United States
GSK Clinical Trials Call Center
Armonk, New York, United States
GSK Clinical Trials Call Center
Brooklyn, New York, United States
GSK Clinical Trials Call Center
New York, New York, United States
GSK Clinical Trials Call Center
Rockville Centre, New York, United States
GSK Clinical Trials Call Center
White Plains, New York, United States
GSK Clinical Trials Call Center
Charlotte, North Carolina, United States
GSK Clinical Trials Call Center
Goldsboro, North Carolina, United States
GSK Clinical Trials Call Center
Greensboro, North Carolina, United States
GSK Clinical Trials Call Center
Greenville, North Carolina, United States
GSK Clinical Trials Call Center
Hickory, North Carolina, United States
GSK Clinical Trials Call Center
Cincinnati, Ohio, United States
GSK Clinical Trials Call Center
Altoona, Pennsylvania, United States
GSK Clinical Trials Call Center
Bethlehem, Pennsylvania, United States
GSK Clinical Trials Call Center
Hershey, Pennsylvania, United States
GSK Clinical Trials Call Center
Kingston, Pennsylvania, United States
GSK Clinical Trials Call Center
Lancaster, Pennsylvania, United States
GSK Clinical Trials Call Center
Spartanburg, South Carolina, United States
GSK Clinical Trials Call Center
West Columbia, South Carolina, United States
GSK Clinical Trials Call Center
Germantown, Tennessee, United States
GSK Clinical Trials Call Center
Nashville, Tennessee, United States
GSK Clinical Trials Call Center
Nashville, Tennessee, United States
GSK Clinical Trials Call Center
Burien, Washington, United States
GSK Clinical Trials Call Center
Olympia, Washington, United States
GSK Clinical Trials Call Center
Puyallup, Washington, United States
GSK Clinical Trials Call Center
Yakima, Washington, United States
GSK Clinical Trials Call Center
Edmonton, Alberta, Canada
GSK Clinical Trials Call Center
Winnipeg, Manitoba, Canada
GSK Clinical Trials Call Center
Greater Sudbury, Ontario, Canada
GSK Clinical Trials Call Center
Thunder Bay, Ontario, Canada
GSK Clinical Trials Call Center
Lévis, Quebec, Canada
GSK Clinical Trials Call Center
Montreal, Quebec, Canada
GSK Clinical Trials Call Center
Sainte-Foy, Quebec, Canada
Countries
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Other Identifiers
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EGF20004
Identifier Type: -
Identifier Source: org_study_id
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