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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: lapatinib

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • GSK Clinical Trials Call Center
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2H 2A6
      • GSK Clinical Trials Call Center
  • Ontario
    • Sudbury, Ontario, Canada, P3E 5J1
      • GSK Clinical Trials Call Center
    • Thunder Bay, Ontario, Canada, P7A 7T1
      • GSK Clinical Trials Call Center
  • Quebec
    • Levis, Quebec, Canada, G6V 3Z1
      • GSK Clinical Trials Call Center
    • Montreal, Quebec, Canada, H4J1C5
      • GSK Clinical Trials Call Center
    • Sainte-Foy, Quebec, Canada, G1V 4G5
      • GSK Clinical Trials Call Center
• United States
  • California
    • Los Angeles, California, United States, 90095
      • GSK Clinical Trials Call Center
    • Poway, California, United States, 92064
      • GSK Clinical Trials Call Center
  • Connecticut
    • Torrington, Connecticut, United States, 06790
      • GSK Clinical Trials Call Center
  • Florida
    • 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
      • GSK Clinical Trials Call Center
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • GSK Clinical Trials Call Center
    • Marietta, Georgia, United States, 30060
      • GSK Clinical Trials Call Center
  • Indiana
    • Terre Haute, Indiana, United States, 47802
      • GSK Clinical Trials Call Center
  • Iowa
    • Des Moines, Iowa, United States, 50314
      • GSK Clinical Trials Call Center
  • Louisiana
    • Lafayette, Louisiana, United States, 70506
      • GSK Clinical Trials Call Center
    • New Orleans, Louisiana, United States, 70121
      • GSK Clinical Trials Call Center
  • Maryland
    • Rockville, Maryland, United States, 20850
      • GSK Clinical Trials Call Center
  • Massachusetts
    • Wellesley, Massachusetts, United States, 02481
      • GSK Clinical Trials Call Center
  • Missouri
    • 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
      • GSK Clinical Trials Call Center
  • Montana
    • Billings, Montana, United States, 59101
      • GSK Clinical Trials Call Center
    • Great Falls, Montana, United States, 59405
      • GSK Clinical Trials Call Center
  • Nebraska
    • Omaha, Nebraska, United States, 68198-7680
      • GSK Clinical Trials Call Center
  • New Hampshire
    • Hooksett, New Hampshire, United States, 03106-2505
      • GSK Clinical Trials Call Center
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • GSK Clinical Trials Call Center
    • Summit, New Jersey, United States, 07091
      • GSK Clinical Trials Call Center
  • New York
    • 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
      • GSK Clinical Trials Call Center
  • North Carolina
    • 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
      • GSK Clinical Trials Call Center
    • Greenville, North Carolina, United States, 27834
      • GSK Clinical Trials Call Center
    • Hickory, North Carolina, United States, 28602
      • GSK Clinical Trials Call Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • GSK Clinical Trials Call Center
  • Pennsylvania
    • 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
      • GSK Clinical Trials Call Center
  • South Carolina
    • Spartanburg, South Carolina, United States, 29303
      • GSK Clinical Trials Call Center
    • West Columbia, South Carolina, United States, 29169
      • GSK Clinical Trials Call Center
  • Tennessee
    • 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
      • GSK Clinical Trials Call Center
  • Washington
    • Burien, Washington, United States, 98166
      • GSK Clinical Trials Call Center
    • Olympia, Washington, United States, 98502
      • GSK Clinical Trials Call Center
    • Puyallup, Washington, United States, 98372
      • GSK Clinical Trials Call Center
    • Yakima, Washington, United States, 98902
      • GSK Clinical Trials Call Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Tumor response rate (complete or partial).	6 Months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Investigators: Study Director: GSK Clinical Trial, MD, GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: September 1, 2002
• Primary Completion (Actual): October 1, 2003
• Study Completion (Actual): October 1, 2003

Study Registration Dates

• First Submitted: August 26, 2002
• First Submitted That Met QC Criteria: August 27, 2002
• First Posted (Estimate): August 28, 2002

Study Record Updates

• Last Update Posted (Estimate): July 10, 2014
• Last Update Submitted That Met QC Criteria: July 9, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: colorectal cancer; metastatic; EGFR inhibitor; lapatinib
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Lapatinib
• Other Study ID Numbers: EGF20004