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Home > "I" Clinical Trials Conditions > Imatinib Mesylate in Treating Patients With Metastatic Breast Cancer  Imatinib Mesylate in Treating Patients With Metastatic Breast Cancer
Imatinib Mesylate in Treating Patients With Metastatic Breast Cancer
For Condition: recurrent breast cancer,Male Breast Cancer,stage 4 breast cancer
Status: No longer recruiting
Sponsor(s): M.D. Anderson Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Imatinib mesylate may stop the growth of cancer by blocking the enzymes necessary for tumor cell growth. PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have metastatic breast cancer.
Details: OBJECTIVES: - Determine the efficacy of imatinib mesylate in patients with metastatic breast cancer. - Determine the clinical activity of this drug, in terms of progression-free survival, in these patients. - Determine the toxicity profile and tolerability of this drug in these patients. - Determine serum, tissue, and imaging surrogate endpoints of activity of this drug in these patients. OUTLINE: Patients receive oral imatinib mesylate twice daily. Treatment continues for at least 8 weeks in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 12-18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed metastatic breast cancer - Documented expression of CD117 (c-kit) or platelet-derived growth factor receptor - Adequate tumor tissue from either the primary tumor and/or metastatic disease available for evaluation - Must have received prior chemotherapy with an anthracycline (doxorubicin or epirubicin) and/or taxane (paclitaxel or docetaxel) as adjuvant or for advanced disease - At least 1 unidimensionally measurable lesion - At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan - Bone disease may not be only source of measurable disease - Pleural or peritoneal ascites are not considered measurable disease - No known brain metastases - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - 18 and over Sex - Female or male Menopausal status - Not specified Performance status - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy - More than 12 weeks Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - WBC at least 3,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin normal - AST or ALT no greater than 2.5 times upper limit of normal Renal - Creatinine normal OR - Creatinine clearance at least 60 mL/min Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other - No other uncontrolled concurrent illness - No ongoing or active infection - No prior allergic reaction attributed to compounds of similar chemical or biologic composition to imatinib mesylate - No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix - No psychiatric illness or social situation that would preclude study compliance - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception during and for 1 week after study PRIOR CONCURRENT THERAPY: Biologic therapy - See Chemotherapy - No concurrent biologic agents Chemotherapy - See Disease Characteristics - No more than 2 prior chemotherapy regimens for metastatic disease - Therapy with high-dose regimens or bone marrow transplantation considered 1 regimen - At least 4 weeks since prior chemotherapy (6 weeks for carmustine or mitomycin) and recovered - No concurrent chemotherapy Endocrine therapy - Prior hormonal therapy for stage IV disease and/or as adjuvant therapy allowed Radiotherapy - At least 4 weeks since prior radiotherapy and recovered - Prior localized radiotherapy that does not influence the signal of the evaluable lesion is allowed Surgery - At least 2 weeks since prior minor surgery - At least 4 weeks since prior major surgery - Recovered from prior surgery Other - Low-molecular weight heparin or heparin allowed for anticoagulation - No concurrent warfarin - No concurrent combination antiretroviral therapy for HIV-positive patients - No concurrent investigational therapies or agents - No other concurrent anticancer therapy - No concurrent intake of cola, orange juice, grapefruit, or orange or grapefruit sections
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MassimoCristofanilli, Study Chair, M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Additional Information:
Study ID Numbers: CDR0000256915; NCI-5580,MDA-ID-01691
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00045188
Other Recurrent Breast Cancer Studies:
1. Metronomic Low-Dose Cyclophosphamide and Methotrexate With or Without Bevacizumab in Treating Women With Metastatic Breast Cancer
2. Bevacizumab in Treating Patients With Metastatic Breast or Colorectal Cancer Who Received Bevacizumab on a Phase II or Phase III Clinical Trial
3. Radiolabeled SMT-487 in Treating Patients With Refractory Small Cell Lung Cancer or Metastatic Breast Cancer
4. Trastuzumab Plus Interleukin-2 in Treating Patients With Metastatic Breast Cancer
5. Oblimersen Plus Doxorubicin and Docetaxel in Treating Patients With Metastatic or Locally Advanced Breast Cancer
Related Studies:
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Imatinib Mesylate in Treating Patients With Metastatic Breast Cancer
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