GW572016, An Oral Drug For Colorectal Cancer Patients Having Prior Therapy With 5-FU Plus CPT-11 And/Or Oxaliplatin
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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.
An Open-Label, Multicenter, Phase II Study of Oral Lapatinib (GW572016) as Single Agent, Second-Line Therapy in Subjects With Metastatic Colorectal Cancer Who Have Progressed on First-Line Therapy With 5-Fluorouracil in Combination With Irinotecan or Oxaliplatin
Study Start Date
Actual Primary Completion Date
Actual Study Completion Date
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.
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.