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Epirubicin, Docetaxel, and Pegfilgrastim in Treating Women With Locally Advanced or Inflammatory Breast Cancer Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Epirubicin, Docetaxel, and Pegfilgrastim in Treating Women With Locally Advanced or Inflammatory Breast Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Epirubicin, Docetaxel, and Pegfilgrastim in Treating Women With Locally Advanced or Inflammatory Breast Cancer Clinical research trials and Epirubicin, Docetaxel, and Pegfilgrastim in Treating Women With Locally Advanced or Inflammatory Breast Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Epirubicin, Docetaxel, and Pegfilgrastim in Treating Women With Locally Advanced or Inflammatory Breast Cancer. Epirubicin, Docetaxel, and Pegfilgrastim in Treating Women With Locally Advanced or Inflammatory Breast Cancer Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Epirubicin, Docetaxel, and Pegfilgrastim in Treating Women With Locally Advanced or Inflammatory Breast Cancer clinical trial. Subjects often receive the most expert healthcare possible for their Epirubicin, Docetaxel, and Pegfilgrastim in Treating Women With Locally Advanced or Inflammatory Breast Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > Epirubicin, Docetaxel, and Pegfilgrastim in Treating Women With Locally Advanced or Inflammatory Breast Cancer  Epirubicin, Docetaxel, and Pegfilgrastim in Treating Women With Locally Advanced or Inflammatory Breast Cancer
Epirubicin, Docetaxel, and Pegfilgrastim in Treating Women With Locally Advanced or Inflammatory Breast Cancer
For Condition: stage 3B breast cancer,inflammatory breast cancer,stage 3C breast cancer,stage 3A breast cancer
Status: Recruiting
Sponsor(s): National Cancer Institute of Canada ,
Synopsis: RATIONALE: Drugs used in chemotherapy such as epirubicin and docetaxel use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as pegfilgrastim 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 combining epirubicin and docetaxel with pegfilgrastim in treating women who have locally advanced or inflammatory breast cancer.
Details: OBJECTIVES: - Determine the maximum tolerated dose and recommended phase II dose of docetaxel and epirubicin when given with pegfilgrastim in women with locally advanced or inflammatory breast cancer. - Determine the toxicity of this regimen in these patients. - Determine the clinical and pathological response rate and duration of response in patients treated with this regimen. - Determine drug sensitivity and resistance in patients treated with this regimen. - Determine prognostic and predictive markers in patients treated with this regimen. OUTLINE: This is a nonrandomized, multicenter, dose-escalation study of docetaxel and epirubicin. - Patients receive epirubicin IV over 15 minutes and docetaxel IV over 60 minutes on day 1 and pegfilgrastim subcutaneously on day 2. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with objective response after 6 courses may receive additional therapy at the discretion of the physician. 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 at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. - Phase II: Patients receive treatment as in phase I with epirubicin and docetaxel at the MTD. Patients are followed at 1 month, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 30-50 patients (15-20 for phase I and 15-30 for phase II) will be accrued for this study within 10-12 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed invasive adenocarcinoma of the breast, meeting any of the following criteria: - T4, NX, M0 - N2-N3, M0 - Inflammatory breast cancer (redness over at least one-third of the breast), M0 - No evidence of metastatic disease by chest x-ray, abdominal ultrasound, or CT scan - Diagnosed within the past 4 weeks - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - 16 and over Sex - Female Menopausal status - Not specified Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Absolute granulocyte count at least 2,000/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10 g/dL Hepatic - Bilirubin less than upper limit of normal (ULN) - Must meet criteria for 1 of the following: - ALT and AST no greater than 1.5 times ULN AND alkaline phosphatase no greater than 2.5 times ULN - ALT and AST normal AND alkaline phosphatase no greater than 5 times ULN Renal - Creatinine no greater than 1.5 times ULN Cardiovascular - Resting LVEF normal by MUGA or echocardiogram - No congestive heart failure - No angina pectoris - No myocardial infarction within the past year - No uncontrolled hypertension - No uncontrolled arrhythmias Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix - No symptomatic peripheral neuropathy grade 2 or greater - No active infection - No history of significant neurological or psychiatric disorders, including dementia or seizures - No peptic ulcer - No unstable diabetes mellitus - No contraindication to dexamethasone - No known sensitivity to E. coli-derived or polyethylene glycol products - Willing to undergo 2 core biopsies while on study - Geographically accessible for treatment and follow-up PRIOR CONCURRENT THERAPY: Biologic therapy - No prior immunotherapy for breast cancer Chemotherapy - No prior chemotherapy for breast cancer Endocrine therapy - No prior hormonal therapy for breast cancer - No concurrent corticosteroids except for premedication or hypersensitivity reaction - No concurrent oral contraception Radiotherapy - No prior radiotherapy for breast cancer Surgery - No prior surgery for breast cancer other than biopsy Other - No prior systemic therapy for breast cancer - No other concurrent investigational drugs or anticancer treatment - No concurrent preventative IV antibiotics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MaureenTrudeau, Study Chair, Toronto Sunnybrook Regional Cancer Centre
Toronto Sunnybrook Regional Cancer Centre *Recruiting*
Toronto, Ontario, M4N 3M5
Canada
Recruiting Kathleen Pritchard 416-480-4616
Additional Information:
Study ID Numbers: CDR0000316237; CAN-NCIC-MA22
Study Start Date:
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00066443
Other Stage 3c Breast Cancer Studies:
1. Vaccine Therapy, Interleukin-2, and Sargramostim in Treating Patients With Advanced Tumors
2. Combination Chemotherapy, Amifostine, and Peripheral Stem Cell Transplantation in Treating Patients With Stage II, Stage III, or Stage IV Breast Cancer
3. Prolonged Tamoxifen Compared With Shorter Tamoxifen in Treating Patients Who Have Breast Cancer
4. Combination Chemotherapy Plus Biological Therapy in Treating Patients With Stage II or Stage III Breast Cancer
5. BMS-247550 in Treating Patients With Locally Advanced or Metastatic Breast Cancer
Related Studies:
Other stage 3C breast cancer Clinical Trials
Other Ontario Clinical Trials
Other Toronto Clinical Trials
Epirubicin, Docetaxel, and Pegfilgrastim in Treating Women With Locally Advanced or Inflammatory Breast Cancer
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