Capecitabine and Vinorelbine in Treating Older Women Who Have Metastatic Breast Cancer With or Without Bone Involvement

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of capecitabine and vinorelbine and to see how well they work in treating older women with metastatic breast cancer with or without bone involvement.

Detailed Description
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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.

Official Title
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Phase I/II of Capecitabine and Vinorelbine in Elderly Patients (At Least 65 Years) With Metastatic Breast Cancer With or Without Bone Involvement

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: capecitabine
* Drug: vinorelbine tartrate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: capecitabine|nan|
|Drug: vinorelbine tartrate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum-tolerated dose (phase I) |  |  | 
| Response rate at the end of study treatment (phase II) |  |  | 
| Toxicity at the end of study treatment (phase II) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to treatment failure at end of study treatment (phase II) |  |  | 
| Quality of life by Linear Analogue Self-Assessment indicators with 6 assessments until the end of the course 4 (phase II) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV breast cancer