GW572016, An Oral Drug For Colorectal Cancer Patients Having Prior Therapy With 5-FU Plus CPT-11 And/Or Oxaliplatin

Completed · Phase 2

Conditions studied: Colorectal Cancer

In brief

The purpose of this study is to determine the efficacy of an oral investigational drug in patients with refractory metastatic colorectal cancer after receiving prior therapy with 5-fluorouracil in combination with irinotecan and/or oxaliplatin.

Key facts

Study ID

NCT00044343

Run by

GlaxoSmithKline

People needed

80

Starts

2002-09-01

Expected to finish

2003-10-01

Last updated by the study team

2014-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provide signed informed consent.
• 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.

You may not qualify if…

• Pregnant or lactating female.
• 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.

Where it is running

• 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 — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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