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.
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
||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 March 31, 2015
Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors