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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: lapatinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: lapatinib|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response rate (complete or partial). |  | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to response duration of response time to progression 4-month progression-free survival 6-month progression-free survival overall survival safety data biomarkers |  | 6 Month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EGFR inhibitor, colorectal cancer, lapatinib, metastatic