Phase II Trial of Lapatinib & Capecitabine for Patients With Refractory Advanced Colorectal Adenocarcinoma
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|ClinicalTrials.gov Identifier: NCT00574171|
Recruitment Status : Completed
First Posted : December 17, 2007
Results First Posted : July 14, 2015
Last Update Posted : March 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Colorectal Cancer||Drug: lapatinib Drug: Capecitabine||Phase 2|
- To evaluate the response rate of lapatinib and capecitabine combination in patients with metastatic colon or rectal cancer.
- To evaluate the toxicity and tolerability of lapatinib and capecitabine in this population.
- To determine overall survival and disease free survival of lapatinib and capecitabine.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Lapatinib and Capectiabine for Patients With Refractory Advanced Colorectal Adenocarcinoma (LAP109859)|
|Study Start Date :||September 2007|
|Primary Completion Date :||August 2009|
|Study Completion Date :||August 2009|
1250mg by mouth daily one hour before or after breakfast on a continuous basis.
Other Name: TykerbDrug: Capecitabine
2000mg/m2 of body surface area (BSA), by mouth, divided into twice daily dosing. Capecitabine will be given for days 1 through 14 of a 21 day cycle.
Other Name: Xeloda
- Response Rate of Lapatinib/Capecitabine. [ Time Frame: duration of study; on average 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00574171
|United States, Wisconsin|
|University of Wisconsin Paul P. Carbone Comprehensive Cancer Center|
|Madison, Wisconsin, United States, 53792|
|Study Chair:||Alcee J Jumonville, M.D.||Gunderson Lutheran - LaCrosse|