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EAP (Expanded Access Protocol) Of Lapatinib Combined With Capecitabine In Metastatic Breast Cancer - NCT00338247-54601(Clinical Trial 145424)



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City:  La Crosse
State:  
WI
Zip Code: 54601
Conditions: Neoplasms, Breast - Breast Cancer
Purpose: This study will provide pre-approval drug access to lapatinib, in combination with capecitabine, to patients whose breast cancer had progressed on other therapies
Study summary:
Criteria: Inclusion criteria: - May have received prior lapatinib in another trial. Previous capecitabine (as previous agent or non-lapatinib containing regimen) is also permitted. - Prior treatment with hormonal therapy is allowed. - Must have advanced or metastatic breast cancer with progression (as assessed by modified RECIST) after prior therapy, which must include all of the following: prior treatment with an anthracycline, a taxane, and trastuzumab alone or in combination with other therapy. Trastuzumab must have been administered in the adjuvant, or locally advanced or metastatic setting. - Must have tumors that overexpress ErbB2 defined as +3 by IHC or FISH positive for ErbB2 gene amplification. The status of ErbB2 expression must be documented prior to study entry. - Must be >/= 18 years of age - Life expectancy of > 8 weeks - Must have recovered from side effects of previous treatment - Patients with CNS mets are eligible provided treatment with prohibited medications as listed in the protocol are not required - Cardiac ejection fraction must be within the institutional range of normal as measured by ECHO. MUGA scans are allowed if ECHOs cannot be performed - Able to swallow and retain oral medications - Must have adequate hematologic, hepatic and renal function Exclusion criteria: - Pregnant or lactating females - Malabsorption syndrome, disease significantly affecting GI function, or resection of the stomach or bowel, or ulcerative colitis - Concurrent disease or condition that would make the patient inappropriate for study participation - Unresolved or unstable toxicity from prior administration of another investigational drug and/or prior cancer treatment - Uncontrolled infection - Active cardiac disease defined as history of uncontrolled or symptomatic angina; history of arrhythmias requiring medication, or clinically significant, with the exception of asymptomatic atrial fibrillation requiring anticoagulation; MI < 6 months from study entry; uncontrolled or symptomatic CHF; ejection fraction below the institutional normal limit; any other cardiac condition that would make this protocol unreasonably hazardous for the patient - Receiving concurrent chemotherapy (other than capecitabine), radiation therapy, immunotherapy, biologic therapy or hormonal therapy for cancer. Concurrent therapy with bisphosphonates is allowed - History of allergic reaction attributed to compounds of similar composition to lapatinib or any excipients - History of allergic reactions attributed to compounds of similar chemical composition to capecitabine, fluorouracil or excipients - Known DPD deficiency
Study is available at: GSK Investigational Site
La Crosse, WI 54601
United States

Primary Contact:
US GSK Clinical Trials Call Center
Email: GSKClinicalSupportHD@gsk.com
Phone: 877-379-3718
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 21, 2011
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