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Home > "D" Clinical Trials Conditions > Doxorubicin and Docetaxel in Treating Women With Stage III Breast Cancer  Doxorubicin and Docetaxel in Treating Women With Stage III Breast Cancer
Doxorubicin and Docetaxel in Treating Women With Stage III Breast Cancer
For Condition: stage 3B breast cancer,inflammatory breast cancer,stage 3A breast cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , H. Lee Moffitt Cancer Center and Research Institute
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of doxorubicin and docetaxel in treating women who have stage III breast cancer.
Details: OBJECTIVES: I. Evaluate the clinical and pathological response rate of sequential doxorubicin and docetaxel chemotherapy in the neoadjuvant treatment of women with stage III breast cancer. II. Measure signal transducer and activator of transcription (STAT) activation before and after this neoadjuvant chemotherapy regimen in this patient population. III. Correlate response to chemotherapy with STAT activation before and after this neoadjuvant chemotherapy regimen in these patients. IV. Determine how other potential predictors of response correlate with STAT activation by measuring Bcl-2, Bcl-xL, Bax protein levels, tyrosine kinase levels, growth rate of the tumor, and apoptotic index before and after this neoadjuvant chemotherapy regimen in these patients. V. Correlate response to chemotherapy with levels of STAT activation in association with the presence of Bcl-2 proteins and tyrosine kinases, growth rate of the tumor, and apoptotic index in these patients. VI. Evaluate the toxicity of this neoadjuvant chemotherapy regimen given in a dose-dense fashion in these patients. PROTOCOL OUTLINE: Patients receive doxorubicin IV on day 1 every 2 weeks for 3 courses. After 3 weeks of rest, patients receive docetaxel IV over 1 hour on day 1 every 2 weeks for 3 courses. Filgrastim (G-CSF) is administered subcutaneously on days 3-10 of each doxorubicin and docetaxel course. Within 6 weeks of completion of neoadjuvant chemotherapy, patients undergo surgery with mastectomy or lumpectomy and axillary lymph node dissection. PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/70 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or pathologically confirmed stage III breast cancer; Clinical evidence of primary invasive breast tumor greater than 5 cm in dimension (T3) and no evidence of metastatic disease clinically or by staging studies including CT scan of the chest, abdomen, and pelvis, and a bone scan - Inflammatory breast carcinoma defined as diffuse brawny induration of the skin of the breast with an erysipeloid edge due to embolization of the dermal lymphatics and pathologic evidence of dermal lymphatic invasion - No bilateral breast cancer unless synchronous - Hormone receptor status: Not specified --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy - Endocrine therapy: Not specified - Radiotherapy: No prior radiotherapy to the breast - Surgery: Not specified --Patient Characteristics-- - Age: 18 to 70 - Sex: Female - Menopausal status: Not specified - Performance status: ECOG 0-1 - Life expectancy: Not specified - Hematopoietic: WBC at least 3,000/mm3; Absolute neutrophil count at least 1,000/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin less than 2.0 mg/dL; SGOT/SGPT less than 1.5 times upper limit of normal (ULN); Alkaline phosphatase no greater than 4 times ULN provided SGOT/SGPT no greater than ULN - Renal: Creatinine no greater than 1.5 mg/dL - Cardiovascular: If prior cardiac event or ischemia on electrocardiogram, must be cleared by cardiologist; LVEF at least 50% by resting MUGA; No severe cardiac dysfunction; No prior or concurrent angina pectoris, congestive heart failure, or major ventricular arrhythmias; No uncontrolled essential hypertension - Other: Not pregnant or nursing; Fertile patients must use effective nonhormonal barrier contraception; No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or intraductal or lobular carcinoma in situ of the breast; No other serious medical or psychiatric illness that would preclude study consent or treatment; No prior severe and intolerable reactions to filgrastim (G-CSF)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SusanMinton, Study Chair, H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
Additional Information:
Study ID Numbers: CDR0000067771; MCC-IRB-5292,MCC-11971,NCI-G00-1763
Study Start Date: July 2000
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005800
Other Stage 3b Breast Cancer Studies:
1. Docetaxel With or Without Bevacizumab Followed by Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Locally Advanced Breast Cancer
2. Doxorubicin and Paclitaxel in Treating Women With Locally Advanced Breast Cancer
3. Chemotherapy Combined With Gene Therapy in Treating Patients Who Have Stage III or Stage IV Breast Cancer
4. Combination Chemotherapy, Amifostine, and Peripheral Stem Cell Transplantation in Treating Patients With Stage II, Stage III, or Stage IV Breast Cancer
5. Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer
Related Studies:
Other stage 3B breast cancer Clinical Trials
Other Florida Clinical Trials
Other Tampa Clinical Trials
Doxorubicin and Docetaxel in Treating Women With Stage III Breast Cancer
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