Phase I/II Trial of Capecitabine With Weekly Paclitaxel for Advanced Breast Cancer
18 Years
64 Years
Both
Breast Cancer
Trial Information
Phase I/II Trial of Capecitabine With Weekly Paclitaxel for Advanced Breast Cancer
OBJECTIVES:
- Determine the maximum tolerated dose (MTD) of capecitabine when combined with
paclitaxel in patients with metastatic adenocarcinoma of the breast.
- Determine the clinical efficacy of the dose immediately preceding the MTD identified in
phase I, in terms of response rate, time to treatment failure, time to disease
progression, and overall survival, in these patients.
- Determine the toxicity of this regimen in these patients.
- Determine a well-tolerated drug combination for these patients.
OUTLINE: This is a dose-escalation, multicenter study of capecitabine.
Patients receive oral capecitabine twice daily on days 1-14 and paclitaxel IV over 1 hour on
days 1, 8, and 15. 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 until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose at which 2 or more of 6 patients
experience dose-limiting toxicity. Once the MTD is determined, additional patients are
treated at the dose level immediately preceding the MTD.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for phase I and 15-46 patients
will be accrued for phase II of this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed metastatic adenocarcinoma of the breast
- Patients in phase I:
- Evaluable disease
- Patients in phase II:
- Bidimensionally measurable disease
- Bone metastases are not considered measurable
- No known or clinically suspected CNS metastases
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 18 to 64
Sex:
- Not specified
Menopausal status:
- Not specified
Performance status:
- WHO 0-2
Life expectancy:
- At least 12 weeks
Hematopoietic:
- WBC greater than 3,500/mm^3
- Platelet count greater than 100,000/mm^3
- Hemoglobin at least 10 g/dL
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST/ALT no greater than 2 times ULN (3 times ULN if liver metastases present)
Renal:
- Patients in phase I:
- Creatinine clearance at least 50 mL/min
- Patients in phase I or II:
- Creatinine no greater than 1.5 times ULN
Cardiovascular:
- No grade 2 or greater atrioventricular block
Other:
- No cognitive impairment or severe psychiatric disorder
- No greater than grade 2 preexisting peripheral neuropathy
- No other prior or concurrent malignancy except adequately treated carcinoma in situ
of the cervix or basal cell or squamous cell skin cancer
- Able to tolerate steroid premedication
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- More than 6 months since prior adjuvant chemotherapy
- At least 1 year since prior continuous infusion of fluorouracil or capecitabine
- At least 1 year since prior taxane administered once every 3 weeks
- No prior taxane or capecitabine administered weekly
- No more than 1 prior chemotherapy regimen for metastatic or locally advanced breast
cancer
- No other concurrent chemotherapy
Endocrine therapy:
- Prior hormonal treatment for metastatic breast cancer allowed
- No concurrent continuous glucocorticosteroids
- No concurrent systemic endocrine treatment for breast cancer
Radiotherapy:
- No concurrent radiotherapy to indicator lesion or more than 30% of bone marrow
Surgery:
- Not specified
Other:
- No other concurrent anticancer treatment
- No concurrent immunosuppressive drugs
- Concurrent bisphosphonates allowed if indicator lesion is non-bone
- Able to tolerate steroid premedication
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Stefan Aebi, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University Hospital Inselspital, Berne
Authority:
Switzerland: Swissmedic
Study ID:
SAKK 26/00
NCT ID:
NCT00031876
Start Date:
May 2000
Completion Date:
September 2004
Related Keywords:
- Breast Cancer
- stage IV breast cancer
- recurrent breast cancer
- Breast Neoplasms
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