Phase II Trial Of Imatinib Mesylate (Gleevec®) (NSC-716051) In Combination With Capecitabine (Xeloda®) (NSC-712807) In Metastatic Breast Cancer
18 Years
N/A
Female
Breast Cancer
Trial Information
Phase II Trial Of Imatinib Mesylate (Gleevec®) (NSC-716051) In Combination With Capecitabine (Xeloda®) (NSC-712807) In Metastatic Breast Cancer
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 the 6-month progression-free survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Correlate, preliminarily, c-kit and platelet-derived growth factor receptor expression
with estrogen and progesterone receptor status, response, survival, and time to disease
progression in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive oral imatinib mesylate* once daily on days 1-21 and oral capecitabine twice
daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or
unacceptable toxicity.
NOTE: *If the patient tolerates the starting dose of imatinib mesylate in course 1, the dose
will be increased in subsequent courses.
Patients are followed every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 25-70 patients (25-45 patients with measurable disease and 25
with non-measurable disease) will be accrued for this study within 2 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed adenocarcinoma of the breast
- Stage IV disease
- 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 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 CNS disease
- Hormone receptor status:
- Receptor status known
PATIENT CHARACTERISTICS:
Age
- 18 and over
Sex
- Female
Menopausal status
- Not specified
Performance status
- Zubrod 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count > 1,500/mm^3
- Leukocyte count > 3,000/mm^3
- Platelet count > 100,000/mm^3
Hepatic
- Bilirubin normal
- AST and ALT < 2.5 times upper limit of normal
Renal
- Creatinine normal OR
- Creatinine clearance > 60 mL/min
Other
- 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
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- No prior biologic therapy (e.g., vaccines)
- No concurrent filgrastim (G-CSF) for chemotherapy-induced neutropenia
Chemotherapy
- See Disease Characteristics
- No prior capecitabine or fluorouracil for metastatic breast cancer
Endocrine therapy
- See Disease Characteristics
- Prior hormonal therapy allowed
Radiotherapy
- More than 4 weeks since prior radiotherapy
- Previously irradiated area(s) must not be the only site of disease
Surgery
- More than 4 weeks since prior major surgery
Other
- 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Confirmed response rate (complete and partial)
Safety Issue:
No
Principal Investigator
Helen K. Chew, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of California, Davis
Authority:
United States: Federal Government
Study ID:
CDR0000372950
NCT ID:
NCT00087152
Start Date:
June 2004
Completion Date:
Related Keywords:
- Breast Cancer
- stage IV breast cancer
- recurrent breast cancer
- Breast Neoplasms
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