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

Phase 2

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT00044343
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2002-08-26
• Study First Submitted QC: 2002-08-27
• Study First Posted: 2002-08-28
• Study Start: 2002-09
• Primary Completion: 2003-10
• Study Completion: 2003-10
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-09
• Last Update Posted: 2014-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Tumor response rate (complete or partial).	6 Months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

GSK Clinical Trials Call Center; 🇨🇦 Sainte-Foy, Quebec, Canada