Phase II Randomized Study of Two Different Schedules of Docetaxel or Paclitaxel for Metastatic Breast Cancer
18 Years
75 Years
Female
Breast Cancer
Trial Information
Phase II Randomized Study of Two Different Schedules of Docetaxel or Paclitaxel for Metastatic Breast Cancer
OBJECTIVES:
- Compare the response rate, progression free survival, and overall survival in women
with unresectable locally advanced or metastatic breast cancer treated with two
different schedules of docetaxel or paclitaxel.
- Compare the toxicities and pharmacoeconomics of these four regimens in these patients.
- Compare the quality of life of patients treated with these four regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, age,
ECOG performance status, hormone receptor status (positive vs negative), metastasis to liver
(yes vs no), and presence of disease progression following anthracyclines (yes vs no).
Patients are randomized to one of four treatment arms.
- Arm I: Patients receive docetaxel IV over 1 hour on day 1.
- Arm II: Patients receive paclitaxel IV over 3 hours on day 1.
- Arm III: Patients receive docetaxel IV over 1 hour on days 1, 8, 15, 22, 29, and 36.
- Arm IV: Patients receive paclitaxel IV over 1 hour on days 1, 8, 15, 22, 29, and 36.
Courses repeat every 3 weeks (arms I and II) or every 8 weeks (arms III and IV) in the
absence of disease progression or unacceptable toxicity.
Quality of life is assessed prior to treatment and then every 8 weeks.
PROJECTED ACCRUAL: A total of 165 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically proven unresectable locally advanced or metastatic breast cancer
- Refractory or relapsed disease after neoadjuvant or adjuvant anthracyclines
- At least one bidimensionally measurable lesion
- No brain metastasis
- No bone metastases, lymphangitis carcinomatous, ascites, or pleural effusion as sole
site of metastatic disease
- Hormone receptor status:
- Known hormone receptor status
PATIENT CHARACTERISTICS:
Age:
- 18 to 75
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- ECOG 0-2 OR
- Karnofsky 60-100%
Life expectancy:
- At least 12 weeks
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- AST and ALT no greater than 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase no greater than 2.5 times ULN
- Bilirubin normal
Renal:
- Creatinine no greater than 1.5 times ULN
Cardiovascular:
- No uncontrolled angina or arrhythmia
- No myocardial infarction within the past 6 months
- No New York Heart Association class III or IV heart disease
Other:
- No sensitive neuropathy worse than grade 2
- No other significant, uncontrolled medical or psychiatric condition
- No serious active infection
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other prior malignancy except treated nonmelanomatous skin cancer or carcinoma in
situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior specific antitumoral immunotherapy
Chemotherapy:
- See Disease Characteristics
- No prior taxanes
- At least 4 weeks since other prior specific antitumoral chemotherapy
Endocrine therapy:
- At least 4 weeks since prior specific antitumoral hormonal therapy
Radiotherapy:
- At least 4 weeks since prior specific antitumoral radiotherapy
Surgery:
- Not specified
Other:
- No other concurrent experimental medication
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Joseph Gligorov, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Hopital Tenon
Authority:
United States: Federal Government
Study ID:
CDR0000068134
NCT ID:
NCT00006120
Start Date:
May 2000
Completion Date:
Related Keywords:
- Breast Cancer
- stage IV breast cancer
- stage IIIA breast cancer
- recurrent breast cancer
- stage IIIB breast cancer
- Breast Neoplasms
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