Phase I/II of Capecitabine and Vinorelbine in Elderly Patients (At Least 65 Years) With Metastatic Breast Cancer With or Without Bone Involvement
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Maximum-tolerated dose (phase I)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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:
- •65 and over
- •Menopausal status:
- •Postmenopausal
- •Performance status:
- •ECOG/SAKK 0-2
- •Life expectancy:
- •At least 12 weeks
- •Hematopoietic:
- •Normal peripheral blood counts
- •AST no greater than 2 times upper limit of normal (ULN) (no greater than 3 times ULN if liver metastases present)
- •Creatinine no greater than 1.5 times ULN
- •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
- •Not specified
- •Bisphosphonates allowed if indicator lesion in nonbone site
排除标准
- 未提供
结局指标
主要结局
Maximum-tolerated dose (phase I)
Response rate at the end of study treatment (phase II)
Toxicity at the end of study treatment (phase II)
次要结局
- 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)