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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00044343
Recruitment Status : Completed
First Posted : August 28, 2002
Last Update Posted : July 10, 2014
Information provided by (Responsible Party):

Tracking Information
First Submitted Date  ICMJE August 26, 2002
First Posted Date  ICMJE August 28, 2002
Last Update Posted Date July 10, 2014
Study Start Date  ICMJE September 2002
Actual Primary Completion Date October 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2007)
Tumor response rate (complete or partial). [ Time Frame: 6 Months ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2007)
Time to response duration of response time to progression 4-month progression-free survival 6-month progression-free survival overall survival safety data biomarkers [ Time Frame: 6 Month ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE GW572016, An Oral Drug For Colorectal Cancer Patients Having Prior Therapy With 5-FU Plus CPT-11 And/Or Oxaliplatin
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE Drug: lapatinib
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 13, 2006)
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 2003
Actual Primary Completion Date October 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00044343
Other Study ID Numbers  ICMJE EGF20004
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trial, MD GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP