Clinical trial NCT00044343: GW572016, An Oral Drug For Colorectal Cancer Patients Having Prior Therapy With 5-FU Plus CPT-11 And/Or Oxaliplatin
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Keywords: colorectal cancer
EGFR inhibitor
lapatinib
metastatic
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2002-08-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Tumor response rate (complete or partial).
timeFrame: 6 Months
Secondary outcomes:
measure: Time to response duration of response time to progression 4-month progression-free survival 6-month progression-free survival overall survival safety data biomarkers
timeFrame: 6 Month
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: GSK Clinical Trials Call Center
state: California
city: Poway
country: United States
facility: GSK Clinical Trials Call Center
state: California
city: Torrington
country: United States
facility: GSK Clinical Trials Call Center
state: Connecticut
city: Boca Raton
country: United States
facility: GSK Clinical Trials Call Center
state: Florida
city: Fort Lauderdale
country: United States
facility: GSK Clinical Trials Call Center
state: Florida
city: Fort Myers
country: United States
facility: GSK Clinical Trials Call Center
state: Florida
city: Miami
country: United States
facility: GSK Clinical Trials Call Center
state: Florida
city: Sarasota
country: United States
facility: GSK Clinical Trials Call Center
state: Florida
city: Atlanta
country: United States
facility: GSK Clinical Trials Call Center
state: Georgia
city: Marietta
country: United States
facility: GSK Clinical Trials Call Center
state: Georgia
city: Terre Haute
country: United States
facility: GSK Clinical Trials Call Center
state: Indiana
city: Des Moines
country: United States
facility: GSK Clinical Trials Call Center
state: Iowa
city: Lafayette
country: United States
facility: GSK Clinical Trials Call Center
state: Louisiana
city: New Orleans
country: United States
facility: GSK Clinical Trials Call Center
state: Louisiana
city: Rockville
country: United States
facility: GSK Clinical Trials Call Center
state: Maryland
city: Wellesley
country: United States
facility: GSK Clinical Trials Call Center
state: Massachusetts
city: St. Charles
country: United States
facility: GSK Clinical Trials Call Center
state: Missouri
city: St. Joseph
country: United States
facility: GSK Clinical Trials Call Center
state: Missouri
city: St. Louis
country: United States
facility: GSK Clinical Trials Call Center
state: Missouri
city: Billings
country: United States
facility: GSK Clinical Trials Call Center
state: Montana
city: Great Falls
country: United States
facility: GSK Clinical Trials Call Center
state: Montana
city: Omaha
country: United States
facility: GSK Clinical Trials Call Center
state: Nebraska
city: Hooksett
country: United States
facility: GSK Clinical Trials Call Center
state: New Hampshire
city: Morristown
country: United States
facility: GSK Clinical Trials Call Center
state: New Jersey
city: Summit
country: United States
facility: GSK Clinical Trials Call Center
state: New Jersey
city: Armonk
country: United States
facility: GSK Clinical Trials Call Center
state: New York
city: Brooklyn
country: United States
facility: GSK Clinical Trials Call Center
state: New York
city: New York
country: United States
facility: GSK Clinical Trials Call Center
state: New York
city: Rockville Centre
country: United States
facility: GSK Clinical Trials Call Center
state: New York
city: White Plains
country: United States
facility: GSK Clinical Trials Call Center
state: New York
city: Charlotte
country: United States
facility: GSK Clinical Trials Call Center
state: North Carolina
city: Goldsboro
country: United States
facility: GSK Clinical Trials Call Center
state: North Carolina
city: Greensboro
country: United States
facility: GSK Clinical Trials Call Center
state: North Carolina
city: Greenville
country: United States
facility: GSK Clinical Trials Call Center
state: North Carolina
city: Hickory
country: United States
facility: GSK Clinical Trials Call Center
state: North Carolina
city: Cincinnati
country: United States
facility: GSK Clinical Trials Call Center
state: Ohio
city: Altoona
country: United States
facility: GSK Clinical Trials Call Center
state: Pennsylvania
city: Bethlehem
country: United States
facility: GSK Clinical Trials Call Center
state: Pennsylvania
city: Hershey
country: United States
facility: GSK Clinical Trials Call Center
state: Pennsylvania
city: Kingston
country: United States
facility: GSK Clinical Trials Call Center
state: Pennsylvania
city: Lancaster
country: United States
facility: GSK Clinical Trials Call Center
state: Pennsylvania
city: Spartanburg
country: United States
facility: GSK Clinical Trials Call Center
state: South Carolina
city: West Columbia
country: United States
facility: GSK Clinical Trials Call Center
state: South Carolina
city: Germantown
country: United States
facility: GSK Clinical Trials Call Center
state: Tennessee
city: Nashville
country: United States
facility: GSK Clinical Trials Call Center
state: Tennessee
city: Nashville
country: United States
facility: GSK Clinical Trials Call Center
state: Tennessee
city: Burien
country: United States
facility: GSK Clinical Trials Call Center
state: Washington
city: Olympia
country: United States
facility: GSK Clinical Trials Call Center
state: Washington
city: Puyallup
country: United States
facility: GSK Clinical Trials Call Center
state: Washington
city: Yakima
country: United States
facility: GSK Clinical Trials Call Center
state: Washington
city: Edmonton
country: Canada
facility: GSK Clinical Trials Call Center
state: Alberta
city: Winnipeg
country: Canada
facility: GSK Clinical Trials Call Center
state: Manitoba
city: Sudbury
country: Canada
facility: GSK Clinical Trials Call Center
state: Ontario
city: Thunder Bay
country: Canada
facility: GSK Clinical Trials Call Center
state: Ontario
city: Levis
country: Canada
facility: GSK Clinical Trials Call Center
state: Quebec
city: Montreal
country: Canada
facility: GSK Clinical Trials Call Center
state: Quebec
city: Sainte-Foy
country: Canada
facility: GSK Clinical Trials Call Center
state: Quebec
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trial, MD
role: STUDY_DIRECTOR
References: