Status:
TERMINATED
Phase I Study of Ixabepilone Plus Lapatinib With or Without Capecitabine in the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer
Lead Sponsor:
R-Pharm
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Locally Advanced or Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the safety and preliminary effectiveness of ixabepilone plus lapatinib with and without capecitabine in the treatment of human epidermal growth factor recepto...
Eligibility Criteria
Inclusion
- Females aged 18 years or older with histologic or cytologic diagnosis of adenocarcinoma originating in the breast
- Radiologic or pathologic evidence that the cancer is metastatic or locally advanced (a T4 tumor and stage IIIB/IIIC disease) and not curable by local measures, such as radiation or surgery
- Positive status for human epidermal growth factor receptor 2
- Measurable disease as per Response Evaluation Criteria In Solid Tumors guidelines
- Karnofsky performance status of 70 to 100
- Life expectancy of at least 3 months
Exclusion
- Prior radiation must not have included 30% or more of major bone-marrow containing areas, such as the pelvis and lumbar spine
- Common Terminology Criteria Grade 2 or greater neuropathy
- Inadequate hematologic, hepatic, or renal function
- Known prior severe hypersensitivity reactions to agents containing Cremophor® EL or known hypersensitivity or prior intolerance to fluoropyrimidine
- Known or suspected dihydropyrimidine dehydrogenase deficiency
- More than 3 prior chemotherapy regimens in the metastatic setting
- Prior treatment with an epothilone or lapatinib; prior treatment with capecitabine within the past 6 months
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00634088
Start Date
June 1 2008
End Date
June 1 2010
Last Update
March 10 2016
Active Locations (3)
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1
The Cancer Institute Of New Jersey
New Brunswick, New Jersey, United States, 08901
2
Local Institution
Brisbane, Queensland, Australia, 4101
3
Local Institution
Modena, Italy, 41100