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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
lapatinib
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring colorectal cancer, EGFR inhibitor, lapatinib, metastatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center

Outcomes

Primary Outcome Measures

Tumor response rate (complete or partial).

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

Full Information

First Posted
August 26, 2002
Last Updated
July 9, 2014
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00044343
Brief Title
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

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
October 2003 (Actual)
Study Completion Date
October 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colorectal cancer, EGFR inhibitor, lapatinib, metastatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
lapatinib
Primary Outcome Measure Information:
Title
Tumor response rate (complete or partial).
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trial, MD
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Clinical Trials Call Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Torrington
State/Province
Connecticut
ZIP/Postal Code
06790
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33428
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33138
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Terre Haute
State/Province
Indiana
ZIP/Postal Code
47802
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70506
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Wellesley
State/Province
Massachusetts
ZIP/Postal Code
02481
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
St. Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
St. Joseph
State/Province
Missouri
ZIP/Postal Code
64507
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63136
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-7680
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Hooksett
State/Province
New Hampshire
ZIP/Postal Code
03106-2505
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07091
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Armonk
State/Province
New York
ZIP/Postal Code
10504
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11570
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
White Plains
State/Province
New York
ZIP/Postal Code
10601
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16601
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Kingston
State/Province
Pennsylvania
ZIP/Postal Code
18704
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17605
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Burien
State/Province
Washington
ZIP/Postal Code
98166
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Olympia
State/Province
Washington
ZIP/Postal Code
98502
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Puyallup
State/Province
Washington
ZIP/Postal Code
98372
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
GSK Clinical Trials Call Center
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Facility Name
GSK Clinical Trials Call Center
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 5J1
Country
Canada
Facility Name
GSK Clinical Trials Call Center
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7A 7T1
Country
Canada
Facility Name
GSK Clinical Trials Call Center
City
Levis
State/Province
Quebec
ZIP/Postal Code
G6V 3Z1
Country
Canada
Facility Name
GSK Clinical Trials Call Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J1C5
Country
Canada
Facility Name
GSK Clinical Trials Call Center
City
Sainte-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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