A Pharmacokinetic Interaction Study Of Docetaxel (Taxotere) 75 mg/mIV On The Combination Therapy Doxorubicin (50 mg/m) And Cyclophosphamide (50 mg/m) In The Treatment Of Advanced Breast Cancer
18 Years
69 Years
Female
Breast Cancer
Trial Information
A Pharmacokinetic Interaction Study Of Docetaxel (Taxotere) 75 mg/mIV On The Combination Therapy Doxorubicin (50 mg/m) And Cyclophosphamide (50 mg/m) In The Treatment Of Advanced Breast Cancer
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Beth A. Overmoyer, MD, FACP
Investigator Role:
Principal Investigator
Investigator Affiliation:
Case Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000343609
NCT ID:
NCT00074139
Start Date:
September 2003
Completion Date:
Related Keywords:
- Breast Cancer
- stage IIIA breast cancer
- recurrent breast cancer
- stage IIIB breast cancer
- stage IIIC breast cancer
- stage IV breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
