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.
Information provided by (Responsible Party):
First received: August 26, 2002
Last updated: July 9, 2014
Last verified: July 2014
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||October 2003 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00044343
||GSK Clinical Trial, MD
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 26, 2002
||July 9, 2014
||United States: Food and Drug Administration
Keywords provided by GlaxoSmithKline:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 14, 2014
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Protein Kinase Inhibitors
Molecular Mechanisms of Pharmacological Action