Phase I/II of Capecitabine and Vinorelbine in Elderly Patients (At Least 65 Years) With Metastatic Breast Cancer With or Without Bone Involvement
65 Years
N/A
Female
Breast Cancer
Trial Information
Phase I/II of Capecitabine and Vinorelbine in Elderly Patients (At Least 65 Years) With Metastatic Breast Cancer With or Without Bone Involvement
OBJECTIVES:
- Determine the maximum tolerated dose of capecitabine and vinorelbine in elderly women
(65 and older) with metastatic breast cancer.
- Evaluate the efficacy and tolerability of this regimen in these patients.
- Assess the time to treatment failure for this regimen as a first line chemotherapy in
these patients.
OUTLINE: This is a dose-escalation study of capecitabine and vinorelbine. Patients are
stratified according to bone involvement (yes [closed to accrual as of 12/7/04] vs no).
- Phase I: Patients receive oral capecitabine twice daily on days 1-14 and vinorelbine IV
over 6-10 minutes on days 1 and 8. Treatment repeats every 21 days for a maximum of 6
courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of capecitabine and vinorelbine until the
maximum tolerated dose (MTD) of each drug is determined. The MTD is defined as the dose at
which 2 of 6 patients experience dose limiting toxicity.
- Phase II: Patients receive capecitabine and vinorelbine administered as in phase I, at
the dose preceding the MTD.
Quality of life is assessed during phase II on days 1, 8, and 15 of course 1 and on day 1 of
courses 2-4.
Patients are followed every 3 months until disease progression or start of any subsequent
antitumor treatment.
PROJECTED ACCRUAL: A total of 98-110 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically proven adenocarcinoma of the breast
- Phase I: Measurable or evaluable disease
- Phase II: Bidimensionally measurable disease
- No CNS metastases
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 65 and over
Sex:
- Female
Menopausal status:
- Postmenopausal
Performance status:
- ECOG/SAKK 0-2
Life expectancy:
- At least 12 weeks
Hematopoietic:
- Normal peripheral blood counts
Hepatic:
- AST no greater than 2 times upper limit of normal (ULN) (no greater than 3 times ULN
if liver metastases present)
Renal:
- Creatinine no greater than 1.5 times ULN
Other:
- No other prior or concurrent malignancy except adequately treated basal or squamous
cell skin cancer or carcinoma in situ of the cervix
- No peripheral neuropathy grade 2 or higher
- No cognitive impairment or severe psychiatric disorder
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- More than 6 months since prior adjuvant chemotherapy
- No prior chemotherapy for metastatic or locally advanced disease
- No other concurrent chemotherapy
Endocrine therapy:
- Prior hormonal therapy for metastatic disease allowed
- No continuous concurrent steroids
- No concurrent systemic endocrine therapy for breast cancer
- No other concurrent endocrine therapy
Radiotherapy:
- No concurrent radiotherapy involving greater than 30% of bone marrow or mucosa
- Radiotherapy to nonindicator lesion allowed
Surgery:
- Not specified
Other:
- Bisphosphonates allowed if indicator lesion in nonbone site
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Maximum-tolerated dose (phase I)
Safety Issue:
No
Principal Investigator
Dagmar Hess, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Kantonsspital St. Gallen
Authority:
Switzerland: Swissmedic
Study ID:
SAKK 25/99
NCT ID:
NCT00003902
Start Date:
March 1999
Completion Date:
September 2005
Related Keywords:
- Breast Cancer
- stage IV breast cancer
- Breast Neoplasms
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