Last updated: 11/04/2018 06:33:24
GW572016, An Oral Drug For Colorectal Cancer Patients Having Prior Therapy With 5-FU Plus CPT-11 And/Or Oxaliplatin
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Tumor response rate (complete or partial).
Timeframe: 6 Months
Secondary outcomes:
Time to response duration of response time to progression 4-month progression-free survival 6-month progression-free survival overall survival safety data biomarkers
Timeframe: 6 Month
Interventions:
Enrollment:
80
Primary completion date:
2003-31-10
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Colorectal Cancer
Product
lapatinib
Collaborators
None
Study date(s)
September 2002 to October 2003
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
no
- Provide signed informed consent.
- Refractory Stage IV metastatic colorectal cancer.
- Pregnant or lactating female.
- Conditions that would affect absorption of an oral drug
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Clinical Trials Call Center
Puyallup, WA, United States, 98372
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Billings, MT, United States, 59101
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
St. Louis, MO, United States, 63136
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Des Moines, IA, United States, 50314
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Levis, QC, Canada, G6V 3Z1
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Thunder Bay, ON, Canada, P7A 7T1
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Edmonton, AB, Canada, T6G 1Z2
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Sainte-Foy, QC, Canada, G1V 4G5
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Montreal, QC, Canada, H4J1C5
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Winnipeg, MB, Canada, R2H 2A6
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Lancaster, PA, United States, 17605
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Terre Haute, IN, United States, 47802
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Kingston, PA, United States, 18704
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Great Falls, MT, United States, 59405
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Altoona, PA, United States, 16601
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Bethlehem, PA, United States, 18015
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Morristown, NJ, United States, 07960
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
St. Joseph, MO, United States, 64507
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Rockville Centre, NY, United States, 11570
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Fort Lauderdale, FL, United States, 33308
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Summit, NJ, United States, 07091
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Burien, WA, United States, 98166
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Nashville, TN, United States, 37203
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Cincinnati, OH, United States, 45219
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Wellesley, MA, United States, 02481
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Hooksett, NH, United States, 03106-2505
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Brooklyn, NY, United States, 11235
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Goldsboro, NC, United States, 27534
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Spartanburg, SC, United States, 29303
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Armonk, NY, United States, 10504
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Torrington, CT, United States, 06790
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Sarasota, FL, United States, 34239
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
White Plains, NY, United States, 10601
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
New Orleans, LA, United States, 70121
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Los Angeles, CA, United States, 90095
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Atlanta, GA, United States, 30309
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Marietta, GA, United States, 30060
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Germantown, TN, United States, 38138
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Poway, CA, United States, 92064
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
West Columbia, SC, United States, 29169
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Greenville, NC, United States, 27834
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Hershey, PA, United States, 17033
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Hickory, NC, United States, 28602
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Olympia, WA, United States, 98502
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
New York, NY, United States, 10032
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
St. Charles, MO, United States, 63301
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Omaha, NE, United States, 68198-7680
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Lafayette, LA, United States, 70506
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Miami, FL, United States, 33138
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Charlotte, NC, United States, 28203
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Nashville, TN, United States, 37205
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Sudbury, ON, Canada, P3E 5J1
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Yakima, WA, United States, 98902
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Greensboro, NC, United States, 27403
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Boca Raton, FL, United States, 33428
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Fort Myers, FL, United States, 33901
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Rockville, MD, United States, 20850
Status
Recruitment Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2003-31-10
Actual study completion date
2003-31-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website