A Randomized Phase II-III Trial Evaluating the Efficacy of Capecitabine and Vinorelbine in Anthracycline and Taxane Pre-Treated Metastatic Breast Cancer
18 Years
N/A
Female
Breast Cancer
Trial Information
A Randomized Phase II-III Trial Evaluating the Efficacy of Capecitabine and Vinorelbine in Anthracycline and Taxane Pre-Treated Metastatic Breast Cancer
OBJECTIVES: Phase II Study:
- Compare the response rate in women with previously treated metastatic breast cancer
treated with capecitabine vs vinorelbine.
- Compare the duration of response in patients treated with these drugs.
Phase III Study:
- Compare overall and progression-free survival in patients treated with these drugs.
- Compare time to treatment failure in patients treated with these drugs.
- Compare overall safety of these drugs in these patients.
- Compare quality of life and clinical benefit response in patients treated with these
drugs.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center and taxane resistance (refractory vs resistant vs sensitive).
- Phase II: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive vinorelbine IV on days 1 and 8. Courses repeat every 21
days.
- Arm II: Patients receive oral capecitabine twice daily on days 1-14. Courses
repeat every 21 days.
In both arms, treatment continues in the absence of progression or unacceptable toxicity.
If sufficient response rate is determined in phase II, the phase III study is initiated.
- Phase III: Patients are randomized and receive treatment as in phase II. Quality of
life is assessed prior to randomization, at weeks 3, 6, 9, 18, 24, and 30, and then
every 12 weeks until disease progression.
Clinical benefit response is assessed daily while patient is on study.
Patients are followed every 6 weeks until disease progression and then every 12 weeks
thereafter.
PROJECTED ACCRUAL: A total of 72 patients (36 per treatment arm) will be accrued for phase
II of this study and a total of 406-452 patients (203-226 per treatment arm) will be accrued
for phase III of this study within 18.5 months.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed breast cancer
- Metastatic disease
- Prior treatment with taxanes in the metastatic, adjuvant, or neoadjuvant setting
- Taxane-resistant disease allowed regardless of duration of prior therapy NOTE:
Resistant disease defined as progression during or within 12 weeks after taxane
therapy for metastatic disease or a disease-free interval of less than 12 months
after neoadjuvant or adjuvant therapy with a taxane
- Taxane-sensitive disease allowed if at least 4 prior courses were received NOTE:
Sensitive disease defined as progression occurring more than 12 weeks after
taxane therapy for metastatic disease or more than 12 months after neoadjuvant
or adjuvant therapy with a taxane
- Prior treatment with anthracyclines for metastatic disease or as adjuvant treatment
OR medical contraindication to treatment with anthracyclines
- At least one unidimensionally measurable lesion (phase II study)
- No CNS metastases
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age
- 18 and over
Sex
- Female
Menopausal status
- Not specified
Performance status
- Karnofsky 70-100%
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 1.25 times upper limit of normal (ULN)
- Transaminases no greater than 2.5 times ULN (5 times ULN if liver metastases present)
Renal
- Creatinine clearance greater than 50 mL/min
Cardiovascular
- No symptomatic ventricular arrhythmias
- No clinically significant congestive heart failure
- No clinical or ECG evidence of myocardial infarction within the past 12 months
- No significant coronary artery disease
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No prior malignancy within the past 5 years except contralateral breast cancer,
nonmelanoma skin cancer, and adequately treated carcinoma in situ of the cervix
- No known or prior sensitivity to fluoropyrimidines, including fluorouracil
- No pre-existing grade 2 or greater neurotoxicity
- No known malabsorption or upper gastrointestinal abnormalities that would affect
absorption of study drug
- No psychological, familial, sociological, or geographical condition that would
preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent biologic therapy
Chemotherapy
- See Disease Characteristics
- No more than 2 prior chemotherapy lines for metastatic disease
- No prior capecitabine, vinca alkaloids, or continuous fluorouracil
- No other concurrent chemotherapy
Endocrine therapy
- Prior hormonal therapy allowed
- No concurrent hormonal therapy
Radiotherapy
- No concurrent radiotherapy
Surgery
- Not specified
Other
- Bisphosphonate therapy for treatment and prevention of bony metastases allowed if
initiated prior to study
- No other concurrent investigational treatment
- No concurrent brivudine with capecitabine
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Martine J. Piccart-Gebhart, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Institut Jules Bordet
Authority:
United States: Federal Government
Study ID:
EORTC-10001-160010
NCT ID:
NCT00049660
Start Date:
September 2002
Completion Date:
Related Keywords:
- Breast Cancer
- stage IV breast cancer
- Breast Neoplasms
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