Expired Study
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Cleveland, Ohio 44106


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 chemotherapy regimen is more effective for breast cancer. PURPOSE: Randomized phase I trial to compare the effectiveness of two regimens of docetaxel combined with doxorubicin and cyclophosphamide in treating women who have advanced breast cancer.

Study summary:

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.


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



Primary Contact:

Principal Investigator
Beth A. Overmoyer, MD, FACP
Case Comprehensive Cancer Center

Backup Contact:


Location Contact:

Cleveland, Ohio 44106
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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