Status:
WITHDRAWN
Docetaxel, Doxorubicin, and Cyclophosphamide in Treating Women With Advanced Breast Cancer
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-69 years
Phase:
PHASE1
Brief Summary
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 d...
Detailed Description
OBJECTIVES: Primary * Determine the pharmacokinetic profile of docetaxel, doxorubicin, and cyclophosphamide in women with advanced breast cancer. Secondary * Compare the pharmacokinetic profile of...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2003
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00074139
Start Date
September 1 2003
End Date
December 1 2003
Last Update
March 5 2014
Active Locations (1)
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1
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5055