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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00044343
• Other study ID #: EGF20004
• Status: Completed
• Phase: Phase 2
• First received: August 26, 2002
• Last updated: July 9, 2014
• Start date: September 2002
• Est. completion date: October 2003

Study information

• Verified date: July 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2003
• Est. primary completion date: October 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• lapatinib

Locations

Country	Name	City	State
Canada	GSK Clinical Trials Call Center	Edmonton	Alberta
Canada	GSK Clinical Trials Call Center	Levis	Quebec
Canada	GSK Clinical Trials Call Center	Montreal	Quebec
Canada	GSK Clinical Trials Call Center	Sainte-Foy	Quebec
Canada	GSK Clinical Trials Call Center	Sudbury	Ontario
Canada	GSK Clinical Trials Call Center	Thunder Bay	Ontario
Canada	GSK Clinical Trials Call Center	Winnipeg	Manitoba
United States	GSK Clinical Trials Call Center	Altoona	Pennsylvania
United States	GSK Clinical Trials Call Center	Armonk	New York
United States	GSK Clinical Trials Call Center	Atlanta	Georgia
United States	GSK Clinical Trials Call Center	Bethlehem	Pennsylvania
United States	GSK Clinical Trials Call Center	Billings	Montana
United States	GSK Clinical Trials Call Center	Boca Raton	Florida
United States	GSK Clinical Trials Call Center	Brooklyn	New York
United States	GSK Clinical Trials Call Center	Burien	Washington
United States	GSK Clinical Trials Call Center	Charlotte	North Carolina
United States	GSK Clinical Trials Call Center	Cincinnati	Ohio
United States	GSK Clinical Trials Call Center	Des Moines	Iowa
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	Germantown	Tennessee
United States	GSK Clinical Trials Call Center	Goldsboro	North Carolina
United States	GSK Clinical Trials Call Center	Great Falls	Montana
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	Hershey	Pennsylvania
United States	GSK Clinical Trials Call Center	Hickory	North Carolina
United States	GSK Clinical Trials Call Center	Hooksett	New Hampshire
United States	GSK Clinical Trials Call Center	Kingston	Pennsylvania
United States	GSK Clinical Trials Call Center	Lafayette	Louisiana
United States	GSK Clinical Trials Call Center	Lancaster	Pennsylvania
United States	GSK Clinical Trials Call Center	Los Angeles	California
United States	GSK Clinical Trials Call Center	Marietta	Georgia
United States	GSK Clinical Trials Call Center	Miami	Florida
United States	GSK Clinical Trials Call Center	Morristown	New Jersey
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	New Orleans	Louisiana
United States	GSK Clinical Trials Call Center	New York	New York
United States	GSK Clinical Trials Call Center	Olympia	Washington
United States	GSK Clinical Trials Call Center	Omaha	Nebraska
United States	GSK Clinical Trials Call Center	Poway	California
United States	GSK Clinical Trials Call Center	Puyallup	Washington
United States	GSK Clinical Trials Call Center	Rockville	Maryland
United States	GSK Clinical Trials Call Center	Rockville Centre	New York
United States	GSK Clinical Trials Call Center	Sarasota	Florida
United States	GSK Clinical Trials Call Center	Spartanburg	South Carolina
United States	GSK Clinical Trials Call Center	St. Charles	Missouri
United States	GSK Clinical Trials Call Center	St. Joseph	Missouri
United States	GSK Clinical Trials Call Center	St. Louis	Missouri
United States	GSK Clinical Trials Call Center	Summit	New Jersey
United States	GSK Clinical Trials Call Center	Terre Haute	Indiana
United States	GSK Clinical Trials Call Center	Torrington	Connecticut
United States	GSK Clinical Trials Call Center	Wellesley	Massachusetts
United States	GSK Clinical Trials Call Center	West Columbia	South Carolina
United States	GSK Clinical Trials Call Center	White Plains	New York
United States	GSK Clinical Trials Call Center	Yakima	Washington

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor response rate (complete or partial).		6 Months
Secondary	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