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
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Drug: lapatinib
Phase 2

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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Tumor response rate (complete or partial). [ Time Frame: 6 Months ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 80
Study Start Date: September 2002
Study Completion Date: October 2003
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00044343

  Hide Study Locations
Locations
United States, California
GSK Clinical Trials Call Center
Los Angeles, California, United States, 90095
GSK Clinical Trials Call Center
Poway, California, United States, 92064
United States, Connecticut
GSK Clinical Trials Call Center
Torrington, Connecticut, United States, 06790
United States, Florida
GSK Clinical Trials Call Center
Boca Raton, Florida, United States, 33428
GSK Clinical Trials Call Center
Fort Lauderdale, Florida, United States, 33308
GSK Clinical Trials Call Center
Fort Myers, Florida, United States, 33901
GSK Clinical Trials Call Center
Miami, Florida, United States, 33138
GSK Clinical Trials Call Center
Sarasota, Florida, United States, 34239
United States, Georgia
GSK Clinical Trials Call Center
Atlanta, Georgia, United States, 30309
GSK Clinical Trials Call Center
Marietta, Georgia, United States, 30060
United States, Indiana
GSK Clinical Trials Call Center
Terre Haute, Indiana, United States, 47802
United States, Iowa
GSK Clinical Trials Call Center
Des Moines, Iowa, United States, 50314
United States, Louisiana
GSK Clinical Trials Call Center
Lafayette, Louisiana, United States, 70506
GSK Clinical Trials Call Center
New Orleans, Louisiana, United States, 70121
United States, Maryland
GSK Clinical Trials Call Center
Rockville, Maryland, United States, 20850
United States, Massachusetts
GSK Clinical Trials Call Center
Wellesley, Massachusetts, United States, 02481
United States, Missouri
GSK Clinical Trials Call Center
St. Charles, Missouri, United States, 63301
GSK Clinical Trials Call Center
St. Joseph, Missouri, United States, 64507
GSK Clinical Trials Call Center
St. Louis, Missouri, United States, 63136
United States, Montana
GSK Clinical Trials Call Center
Billings, Montana, United States, 59101
GSK Clinical Trials Call Center
Great Falls, Montana, United States, 59405
United States, Nebraska
GSK Clinical Trials Call Center
Omaha, Nebraska, United States, 68198-7680
United States, New Hampshire
GSK Clinical Trials Call Center
Hooksett, New Hampshire, United States, 03106-2505
United States, New Jersey
GSK Clinical Trials Call Center
Morristown, New Jersey, United States, 07960
GSK Clinical Trials Call Center
Summit, New Jersey, United States, 07091
United States, New York
GSK Clinical Trials Call Center
Armonk, New York, United States, 10504
GSK Clinical Trials Call Center
Brooklyn, New York, United States, 11235
GSK Clinical Trials Call Center
New York, New York, United States, 10032
GSK Clinical Trials Call Center
Rockville Centre, New York, United States, 11570
GSK Clinical Trials Call Center
White Plains, New York, United States, 10601
United States, North Carolina
GSK Clinical Trials Call Center
Charlotte, North Carolina, United States, 28203
GSK Clinical Trials Call Center
Goldsboro, North Carolina, United States, 27534
GSK Clinical Trials Call Center
Greensboro, North Carolina, United States, 27403
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Greenville, North Carolina, United States, 27834
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Hickory, North Carolina, United States, 28602
United States, Ohio
GSK Clinical Trials Call Center
Cincinnati, Ohio, United States, 45219
United States, Pennsylvania
GSK Clinical Trials Call Center
Altoona, Pennsylvania, United States, 16601
GSK Clinical Trials Call Center
Bethlehem, Pennsylvania, United States, 18015
GSK Clinical Trials Call Center
Hershey, Pennsylvania, United States, 17033
GSK Clinical Trials Call Center
Kingston, Pennsylvania, United States, 18704
GSK Clinical Trials Call Center
Lancaster, Pennsylvania, United States, 17605
United States, South Carolina
GSK Clinical Trials Call Center
Spartanburg, South Carolina, United States, 29303
GSK Clinical Trials Call Center
West Columbia, South Carolina, United States, 29169
United States, Tennessee
GSK Clinical Trials Call Center
Germantown, Tennessee, United States, 38138
GSK Clinical Trials Call Center
Nashville, Tennessee, United States, 37203
GSK Clinical Trials Call Center
Nashville, Tennessee, United States, 37205
United States, Washington
GSK Clinical Trials Call Center
Burien, Washington, United States, 98166
GSK Clinical Trials Call Center
Olympia, Washington, United States, 98502
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Puyallup, Washington, United States, 98372
GSK Clinical Trials Call Center
Yakima, Washington, United States, 98902
Canada, Alberta
GSK Clinical Trials Call Center
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Manitoba
GSK Clinical Trials Call Center
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Ontario
GSK Clinical Trials Call Center
Sudbury, Ontario, Canada, P3E 5J1
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Thunder Bay, Ontario, Canada, P7A 7T1
Canada, Quebec
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Levis, Quebec, Canada, G6V 3Z1
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Montreal, Quebec, Canada, H4J1C5
GSK Clinical Trials Call Center
Sainte-Foy, Quebec, Canada, G1V 4G5
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trial, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00044343     History of Changes
Other Study ID Numbers: EGF20004
Study First Received: August 26, 2002
Last Updated: July 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
colorectal cancer
EGFR inhibitor
lapatinib
metastatic

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Oxaliplatin
Lapatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014