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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00044343
First received: August 26, 2002
Last updated: July 9, 2014
Last verified: July 2014

August 26, 2002
July 9, 2014
September 2002
October 2003   (final data collection date for primary outcome measure)
Tumor response rate (complete or partial). [ Time Frame: 6 Months ]
Not Provided
Complete list of historical versions of study NCT00044343 on ClinicalTrials.gov Archive Site
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 ]
Not Provided
Not Provided
Not Provided
 
GW572016, An Oral Drug For Colorectal Cancer Patients Having Prior Therapy With 5-FU Plus CPT-11 And/Or Oxaliplatin
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

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer
Drug: lapatinib
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
October 2003
October 2003   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00044343
EGF20004
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trial, MD GlaxoSmithKline
GlaxoSmithKline
July 2014

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