Status:
COMPLETED
S0338, Imatinib Mesylate and Capecitabine in Treating Women With Progressive Stage IV Breast Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop tum...
Detailed Description
OBJECTIVES: * Determine the confirmed complete and partial response rate in women with progressive stage IV adenocarcinoma of the breast treated with imatinib mesylate and capecitabine. * Determine t...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed adenocarcinoma of the breast
- Stage IV measurable disease
- Disease progression after at least 1, but no more than 2, prior chemotherapy regimens for metastatic disease
- Patients with hormone-sensitive tumors must have received prior hormonal therapy
- Patients with human epidermal growth factor receptor 2 (HER2)/neu-overexpressing tumors (3+ by immunohistochemistry or amplified by fluorescent in situ hybridization) should have received trastuzumab (Herceptin®) in the adjuvant or metastatic setting (unless contraindicated)
- No clinical evidence of or known brain or central nervous system (CNS) disease
- Hormone Receptor status known
- Female age 18 and over
- Performance status Zubrod 0-2
- Absolute neutrophil count \> 1,500/mm\^3
- Leukocyte count \> 3,000/mm\^3
- Platelet count \> 100,000/mm\^3
- Bilirubin normal
- aspartate aminotransferase (AST) / alanine aminotransferase (ALT) \< 2.5 times upper limit of normal
- Creatinine normal OR Creatinine clearance \> 60 mL/min
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 3 months after study participation
- No history of severe hypersensitivity reaction to compounds of similar chemical or biological composition to imatinib mesylate, capecitabine, or fluorouracil
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- No prior biologic therapy (e.g., vaccines)
- No concurrent filgrastim (G-CSF) for chemotherapy-induced neutropenia
- No prior capecitabine or fluorouracil for metastatic breast cancer
- Prior hormonal therapy allowed
- More than 4 weeks since prior radiotherapy - Previously irradiated area(s) must not be the only site of disease
- More than 4 weeks since prior major surgery
- More than 4 weeks since prior therapy for breast cancer
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent investigational or commercial agents or therapies for metastatic breast cancer
Exclusion
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00087152
Start Date
June 1 2004
End Date
December 1 2008
Last Update
June 9 2014
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