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Docetaxel, Doxorubicin, and Cyclophosphamide in Treating Women With Advanced Breast Cancer Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Docetaxel, Doxorubicin, and Cyclophosphamide in Treating Women With Advanced Breast Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Docetaxel, Doxorubicin, and Cyclophosphamide in Treating Women With Advanced Breast Cancer Clinical research trials and Docetaxel, Doxorubicin, and Cyclophosphamide in Treating Women With Advanced Breast Cancer health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Docetaxel, Doxorubicin, and Cyclophosphamide in Treating Women With Advanced Breast Cancer. Docetaxel, Doxorubicin, and Cyclophosphamide in Treating Women With Advanced Breast Cancer Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Docetaxel, Doxorubicin, and Cyclophosphamide in Treating Women With Advanced Breast Cancer clinical trial. Human subjects often get the best healthcare available for their Docetaxel, Doxorubicin, and Cyclophosphamide in Treating Women With Advanced Breast Cancer condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "D" Clinical Trials Conditions > Docetaxel, Doxorubicin, and Cyclophosphamide in Treating Women With Advanced Breast Cancer  Docetaxel, Doxorubicin, and Cyclophosphamide in Treating Women With Advanced Breast Cancer
Docetaxel, Doxorubicin, and Cyclophosphamide in Treating Women With Advanced Breast Cancer
For Condition: stage 4 breast cancer,stage 3B breast cancer,stage 3C breast cancer,stage 3A breast cancer,recurrent breast cancer
Status: Recruiting
Sponsor(s): Ireland Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as docetaxel, doxorubicin, and cyclophosphamide, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them at different times, may kill more tumor cells. It is not yet known which combination chemotherapyregimen is more effective for breast cancer. PURPOSE: Randomizedphase I trial to compare the effectiveness of two regimens of docetaxel combined with doxorubicin and cyclophosphamide in treating women who have advanced breast cancer.
Details: OBJECTIVES: Primary - Determine the pharmacokinetic profile of docetaxel, doxorubicin, and cyclophosphamide in women with advanced breast cancer. Secondary - Compare the pharmacokinetic profile of this regimen in these patients vs the historical pharmacokinetic profile of docetaxel. OUTLINE: This is a randomized, open-label, crossover, multicenter study. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive doxorubicin IV over 15 minutes and cyclophosphamide IV over 15 minutes on day 1 followed by doxorubicin IV over 15 minutes, cyclophosphamide IV over 15 minutes, and docetaxel IV over 1 hour on day 22. - Arm II: Patients receive doxorubicin IV over 15 minutes, cyclophosphamide IV over 15 minutes, and docetaxel IV over 1 hour on day 1 followed by doxorubicin IV over 15 minutes and cyclophosphamide IV over 15 minutes on day 22. Treatment in both arms continues in the absence of disease progression or unacceptable toxicity. Patients may receive additional therapy at the discretion of the treating physician. Patients are followed at 3-4 weeks. PROJECTED ACCRUAL: A total of 24 patients (12 per treatment arm) will be accrued for this study within 7 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/69 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed advanced breast cancer - Adjuvant setting for high-risk disease allowed - No symptomatic evidence or history of brain metastases - No leptomeningeal metastases - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - 18 to 69 Sex - Female Menopausal status - Not specified Performance status - WHO 0-2 OR - Karnofsky 60-100% Life expectancy - Not specified Hematopoietic - Neutrophil count at least 2,000/mm^3 - Platelet count greater than 100,000/mm^3 - Hemoglobin greater than 10 g/dL Hepatic - Bilirubin less than upper limit of normal (ULN) - AST and ALT no greater than 2.5 times ULN (1.5 times ULN if alkaline phosphatase greater than 2.5 times ULN) - Alkaline phosphatase no greater than 5 times ULN Renal - Creatinine normal OR - Creatinine clearance at least 60 mL/min Cardiovascular - LVEF or shortening fraction greater than lower limit of normal by MUGA or echocardiography - Cardiac function normal - No congestive heart failure - No unstable angina pectoris - No myocardial infarction within the past year - No uncontrolled hypertension - No high-risk uncontrolled arrhythmia Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective nonhormonal contraception - No active uncontrolled infection - No active peptic ulcer - No unstable diabetes mellitus - No other serious illness or medical condition - No contraindication to corticosteroids - No pre-existing grade 2 or greater motor or sensory neurotoxicity - No psychological, social, familial, or geographical reason that would preclude study follow-up - No history of significant neurologic or psychiatric disorder (e.g., psychotic disorder, dementia, or seizures) that would preclude understanding and giving informed consent - No other neoplasm within the past 10 years except curatively treated nonmelanoma skin cancer, carcinoma in situ of the cervix, ipsilateral ductal carcinoma in situ of the breast, or lobular carcinoma in situ of the breast PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - At least 6 months since prior anthracycline or taxoid (e.g., paclitaxel or docetaxel) therapy - No prior cumulative anthracycline dose greater than 240 mg/m^2 Endocrine therapy - Concurrent corticosteroid treatment allowed provided treatment was initiated more than 6 months before study entry and at a dose of less than 20 mg of methylprednisolone or equivalent - No concurrent ovarian hormonal replacement therapy Radiotherapy - Not specified Surgery - More than 2 weeks since prior major surgery Other - More than 30 days since prior participation in another clinical trial with any investigational drug or device - No other concurrent experimental drugs - No other concurrent systemic anticancer therapy - No concurrent aminoglycoside antibiotics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BethOvermoyer, Principal Investigator, Ireland Cancer Center
Ireland Cancer Center *Recruiting*
Cleveland, Ohio, 44106-5055
United States
Recruiting Beth Overmoyer 216-844-3862
Additional Information:
Study ID Numbers: CDR0000343609; CWRU-AVEN-1103,CWRU-040314,AVENTIS-XRP6976D/1001
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00074139
Other Recurrent Breast Cancer Studies:
1. Combination Chemotherapy Before Surgery in Treating Women With Breast Cancer
2. Docetaxel, Doxorubicin, and Cyclophosphamide in Treating Women With Stage III Breast Cancer
3. Celecoxib in Treating Postmenopausal Women Who Are Undergoing Surgery for Invasive Breast Cancer
4. Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer
5. Paclitaxel With or Without Trastuzumab in Treating Patients With Inoperable, Recurrent, or Metastatic Breast Cancer
Related Studies:
Other recurrent breast cancer Clinical Trials
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Docetaxel, Doxorubicin, and Cyclophosphamide in Treating Women With Advanced Breast Cancer
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