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Home > "D" Clinical Trials Conditions > Docetaxel and Epirubicin With and Without G-CSF in Treating Women With Metastatic Breast Cancer  Docetaxel and Epirubicin With and Without G-CSF in Treating Women With Metastatic Breast Cancer
Docetaxel and Epirubicin With and Without G-CSF in Treating Women With Metastatic Breast Cancer
For Condition: stage 4 breast cancer,Neutropenia,recurrent breast cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute of Canada ,
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 G-CSF 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. PURPOSE: Phase I/II trial to study the effectiveness of docetaxel and epirubicin with and without G-CSF in treating women with metastatic breast cancer.
Details: OBJECTIVES: I. Estimate the maximum tolerated dose and recommended phase II dose of docetaxel in combination with epirubicin with or without granulocyte colony-stimulating factor support as first-line therapy in women with metastatic breast cancer (Phase II closed as of 03/27/2000). II. Study the pharmacokinetic profile of docetaxel/epirubicin. III. Evaluate the toxicity of this regimen given at the recommended phase II dose. IV. Evaluate the response rate and duration of response to this regimen given at the recommended phase II dose. PROTOCOL OUTLINE: This is a dose-escalation study of epirubicin and docetaxel. Patients receive epirubicin IV over 15 minutes followed by docetaxel IV over 60 minutes on day 1. Patients also receive filgrastim (G-CSF) subcutaneously on days 4-13. Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of epirubicin and docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose in which 2 or more of 6 patients experience dose-limiting toxicity. Additional patients will be accrued to receive treatment at the recommended phase II dose defined as the dose preceding the MTD (Phase II closed as of 03/27/2000). Patients are followed every 3 months for survival. PROJECTED ACCRUAL: It is estimated that 15-20 patients will be entered over 4-5 months in the phase I portion of the study. A total of 30 evaluable patients will be entered over 7-8 months in the phase II portion of the study (Closed as of 03/27/2000).
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed breast cancer with newly diagnosed or progressive metastatic disease; No brain or leptomeningeal metastasis - Phase I entry: Measurable and/or evaluable disease with an indicator lesion outside prior radiotherapy field - Phase II entry: (Closed as of 03/27/2000) Bidimensionally measurable disease with an indicator lesion outside prior radiotherapy field At least 1 x 1 cm on chest x-ray; At least 2 x 2 cm on CT or ultrasound; Skin lesion or node at least 1 x 1 cm; No bone-only lesion - Hormone receptor status: Not specified --Prior/Concurrent Therapy-- - Biologic therapy: Not specified; No concurrent colony-stimulating factors other than filgrastim - Chemotherapy: Phase I patients: At least 12 months since adjuvant chemotherapy; Prior neoadjuvant chemotherapy allowed; Prior cumulative doxorubicin dose no greater than 300 mg per square meter; Prior cumulative epirubicin dose no greater than 500 mg per square meter; If epirubicin dose level at least 90 mg per square meter: Prior cumulative doxorubicin dose no greater than 200 mg per square meter; Prior cumulative epirubicin dose no greater than 300 mg per square meter - Phase II patients: (Closed as of 03/27/2000) No prior neoadjuvant or adjuvant chemotherapy regimen other than cyclophosphamide/methotrexate/fluorouracil, or doxorubicin/cyclophosphamide given for a maximum of 4 courses - All patients: No prior chemotherapy for metastatic disease; No prior taxanes - Endocrine therapy: Prior hormonal therapy allowed if subsequent disease progression; No more than 2 prior hormonal therapy regimens for metastatic disease; No concurrent corticosteroids (except as premedication or for hypersensitivity reaction) - Radiotherapy: At least 4 weeks since prior radiotherapy (unless single fractions for palliation); Concurrent palliative radiotherapy for painful bone lesions allowed; Concurrent whole brain radiotherapy for brain metastasis allowed - Surgery: Not specified - Other: No other concurrent investigational drugs or anticancer therapy; No concurrent preventive oral or intravenous antibiotics; No concurrent agents known to inhibit cytochrome P450 3A4 --Patient Characteristics-- - Age: 16 and over - Sex: Women only - Menopausal status: Not specified - Performance status: ECOG 0-2 - Hematopoietic: Absolute granulocyte count at least 2,000/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 10 g/dL - Hepatic: Bilirubin normal; AST/ALT no greater than 1.5 times normal; Alkaline phosphatase no greater than 2.5 times normal (no greater than 5.0 times normal if AST/ALT normal) - Renal: Creatinine no greater than 1.5 times normal - Cardiovascular: Left ventricular ejection fraction at rest at least 50% by MUGA or echocardiogram; No congestive heart failure; No angina pectoris (even if controlled); No myocardial infarction within previous year; No uncontrolled arrhythmia; No uncontrolled hypertension - Other: No active infection; No grade 2 or greater peripheral neuropathy; No significant neurologic or psychiatric disorder, including dementia or seizures; No peptic ulcer, unstable diabetes mellitus, or other contraindication to dexamethasone; No prior malignancy except nonmelanomatous skin cancer or excised carcinoma in situ of the cervix; No pregnant or nursing; Fertile patients must use effective contraception; Geographically accessible
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MaureenTrudeau, Study Chair, National Cancer Institute of Canada
Mount Sinai Hospital - Toronto
Toronto, Ontario, M5G 1X5
Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
Canada
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
Canada
Hotel Dieu de Montreal
Montreal, Quebec, H2W 1T8
Canada
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Canada
Women's College Campus, Sunnybrook and Women's College Health Science Center
Toronto, Ontario, M5S 1B6
Canada
Additional Information:
Study ID Numbers: CDR0000065138; CAN-NCIC-MA15,NCI-V96-1063
Study Start Date: August 1996
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002866
Other Recurrent Breast Cancer Studies:
1. Antibiotic Therapy With or Without G-CSF in Treating Children With Neutropenia and Fever Caused by Chemotherapy
2. Combination Chemotherapy in Treating Patients With Chronic Myelogenous Leukemia or Recurrent Acute Leukemia
3. Filgrastim or Pegfilgrastim in Preventing Neutropenia in Women Receiving Chemotherapy Following Surgery for Breast Cancer
4. Peripheral Stem Cell Transplantation to Prevent Neutropenia in Patients Receiving Chemotherapy for Relapsed or Refractory Non-Hodgkin's Lymphoma
5. Cancer in Inherited Bone Marrow Failure Syndromes
Related Studies:
Other recurrent breast cancer Clinical Trials
Other Quebec Clinical Trials
Other Montreal Clinical Trials
Docetaxel and Epirubicin With and Without G-CSF in Treating Women With Metastatic Breast Cancer
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