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Docetaxel in Treating Patients With Metastatic Breast Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Docetaxel in Treating Patients With Metastatic Breast Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Docetaxel in Treating Patients With Metastatic Breast Cancer Clinical research trials and Docetaxel in Treating Patients With Metastatic Breast Cancer healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Docetaxel in Treating Patients With Metastatic Breast Cancer. Docetaxel in Treating Patients With Metastatic Breast Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Docetaxel in Treating Patients With Metastatic Breast Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their Docetaxel in Treating Patients With Metastatic Breast Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > Docetaxel in Treating Patients With Metastatic Breast Cancer  Docetaxel in Treating Patients With Metastatic Breast Cancer
Docetaxel in Treating Patients With Metastatic Breast Cancer
For Condition: recurrent breast cancer,stage 4 breast cancer
Status: Recruiting
Sponsor(s): M.D. Anderson 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. PURPOSE: Randomizedphase III trial to determine the effectiveness of docetaxel in treating patients who have metastatic breast cancer.
Details: OBJECTIVES: - Compare the objective tumor response rate, duration of response, time to progression, progression-free survival, and overall survival in women with metastatic breast cancer treated with docetaxel administered weekly vs every three weeks. - Compare the safety and toxicity of these regimens in these patients. - Evaluate the maintenance of relative dose intensity with each regimen in these patients. - Correlate pretreatment serum HER2/neu level and response with docetaxel therapy in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior taxane use (yes vs no), number of prior chemotherapy regimens for metastatic disease (0 vs 1), and participating center. Patients are randomized to one of two treatment arms. - Arm I: Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days. - Arm II: Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days. Treatment continues in both arms in the absence of disease progression or unacceptable toxicity. Patients are followed at 3 weeks, at 3, 6, 9, and 12 months, and then annually for 4 years. PROJECTED ACCRUAL: A total of 160 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 metastatic breast cancer - Bidimensionally measurable disease - No uncontrolled brain metastases or leptomeningeal disease - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - 18 and over Sex: - Female Menopausal status: - Not specified Performance status: - Zubrod 0-2 Life expectancy: - At least 3 months Hematopoietic: - Platelet count at least 100,000/mm^3 - Neutrophil count at least 1,000/mm^3 - Hemoglobin at least 8 g/dL Hepatic: - Bilirubin no greater than upper limit of normal (ULN) - SGOT/SGPT no greater than 1.5 times ULN (2.5 times ULN provided alkaline phosphatase no greater than ULN) - Alkaline phosphatase no greater than 2.5 times ULN (4 times ULN provided transaminases no greater than ULN) Renal: - Creatinine no greater than 2.0 mg/dL Neurologic: - No peripheral neuropathy grade 2 or greater - Neurologic status must be stable 2 weeks after surgery and/or radiotherapy for brain metastasis - No psychiatric disorders Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other malignancy within the past 5 years except non-melanoma skin cancer, carcinoma in situ of the cervix, or other curatively treated malignancy - No other serious condition or illness, including active infection - No history of hypersensitivity to polysorbate 80 PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Recovered from prior chemotherapy - No more than 2 prior chemotherapy regimens (no more than 1 prior regimen for metastatic disease) - No prior paclitaxel or docetaxel (except in the adjuvant setting) - At least 12 months since prior adjuvant taxane (paclitaxel or docetaxel) - Prior anthracycline-based therapy allowed Endocrine therapy: - Not specified Radiotherapy: - At least 2 weeks since prior radiotherapy and recovered Surgery: - At least 2 weeks since prior surgery and recovered
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EdgardoRivera, Study Chair, M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Edgardo Rivera 713-792-2817
University of Texas M.D. Anderson CCOP Research Base *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting W. Bleyer 713-792-8516
Additional Information:
Study ID Numbers: CDR0000068408; MDA-ID-99242,NCI-1691,AVENTIS-MDA-ID-99242
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00008411
Other Stage 4 Breast Cancer Studies:
1. Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Small Cell Lung, Breast, Testicular, or Kidney Cancer That is Metastatic or That Cannot Be Treated With Surgery
2. Trastuzumab and Radiation Therapy in Treating Women With Stage III or Stage IV Invasive Primary Cancer of the Breast
3. Comparison of Two Regimens of Liposomal Doxorubicin in Treating Women with Metastatic Breast Cancer
4. ERA-923 in Treating Postmenopausal Women With Metastatic Breast Cancer
5. Paclitaxel With or Without Trastuzumab in Treating Patients With Inoperable, Recurrent, or Metastatic Breast Cancer
Related Studies:
Other stage 4 breast cancer Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Docetaxel in Treating Patients With Metastatic Breast Cancer
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