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Home > "C" Clinical Trials Conditions > Combination Chemotherapy and Filgrastim Followed by Radiation Therapy in Treating Patients With Stage II or Stage IIIA Breast Cancer  Combination Chemotherapy and Filgrastim Followed by Radiation Therapy in Treating Patients With Stage II or Stage IIIA Breast Cancer
Combination Chemotherapy and Filgrastim Followed by Radiation Therapy in Treating Patients With Stage II or Stage IIIA Breast Cancer
For Condition: stage 2 breast cancer,stage 3A breast cancer,Male Breast Cancer
Status: Recruiting
Sponsor(s): Ireland Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. Radiation therapy uses high-energy x-rays to damage tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and filgrastim followed by radiation therapy in treating patients who have stage II or stage IIIA breast cancer.
Details: OBJECTIVES: - Determine the feasibility of administering adjuvant paclitaxel, dose-intensive cyclophosphamide, and filgrastim (G-CSF), followed by doxorubicin and then radiotherapy in patients with stage II or IIIA breast cancer involving at least 10 lymph nodes. - Determine the incidence of febrile neutropenia in these patients during the first course of therapy. - Compare the incidence of febrile neutropenia and duration of neutropenia in patients treated with this regimen with that seen in patients treated on protocol CWRU-4194. - Determine the disease-free and overall survival of patients treated with this regimen. - Evaluate the quality of life of these patients. - Determine the prognostic significance of occult bone marrow metastases in these patients. - Correlate HER-2/neu overexpression with disease-free and overall survival in these patients. OUTLINE: Patients receive paclitaxel IV continuously and cyclophosphamide IV over 2 hours on days 1-3. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 5 and continuing until day 14 or until blood counts recover. Treatment repeats every 21 days for 3 courses. Patients then receive doxorubicin IV on day 1 and G-CSF SC on days 2-11 every 21 days for 4 courses. Patients with hormone receptor positive disease also receive oral tamoxifen daily for 5 years beginning at the completion of chemotherapy. Beginning 3-6 weeks after the completion of chemotherapy, patients receive radiotherapy 5 days a week for 6-7 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed days 1 and 4 of the first course of chemotherapy, day 1 of the second course, the last day of the final course, and at 6 months after the completion of treatment. Patients are followed every 3 months for 2 years and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 26 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed stage II or IIIA breast cancer - At least 10 positive axillary lymph nodes - No T4 or N3 disease - No distant metastases by CT scan of the chest, abdomen, and pelvis; bone scan; and bone marrow evaluation - No more than 8 weeks since prior lumpectomy or mastectomy with axillary node dissection - Negative surgical margins - Hormone receptor status: - Hormone receptor status known PATIENT CHARACTERISTICS: Age: - 18 and over Sex: - Male or female Menopausal status: - Not specified Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - WBC at least 3,500/mm^3 - Granulocyte count at least 1,500/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - SGOT no greater than 1.5 times ULN - Alkaline phosphatase no greater than 1.5 times ULN Renal: - Creatinine no greater than 1.5 mg/dL Cardiovascular: - No poorly controlled ischemic heart disease or congestive heart failure Pulmonary: - No severe chronic obstructive or restrictive pulmonary disease Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No severe diabetes mellitus - No other severe concurrent medical or psychiatric illness that would preclude study participation - No other malignancy within past 5 years except curatively treated ductal carcinoma in situ, lobular carcinoma in situ, or breast cancer PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy Surgery: - See Disease Characteristics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BrendaCooper, Study Chair, Ireland Cancer Center
Ireland Cancer Center *Recruiting*
Cleveland, Ohio, 44106-5055
United States
Recruiting Brenda Cooper 216-844-3213
Additional Information:
Study ID Numbers: CDR0000068341; CWRU-1100,CWRU-050023,NCI-G00-1877
Study Start Date:
Record last reviewed: January 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00007904
Other Stage 3a Breast Cancer Studies:
1. BMS-247550 in Treating Patients With Locally Advanced or Metastatic Breast Cancer
2. Irinotecan and Docetaxel in Treating Patients With Refractory Metastatic Breast Cancer
3. Whole Body Hyperthermia Combined With Chemotherapy in Treating Patients With Metastatic Breast, Ovarian, Endometrial, or Cervical Cancer
4. Trastuzumab Plus Interleukin-2 in Treating Patients With Metastatic Breast Cancer
5. CP-724,714 in Treating Patients With Metastatic Breast Cancer
Related Studies:
Other stage 3A breast cancer Clinical Trials
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Combination Chemotherapy and Filgrastim Followed by Radiation Therapy in Treating Patients With Stage II or Stage IIIA Breast Cancer
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