Phase I Study To Determine The Safety Of Caelyx (Doxorubin HCI, Pegylated Liposomal) In Combination With Ifosfamide In Previously Untreated Adult Patients With Advanced And/Or Metastatic Soft Tissues Sarcomas
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
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: Phase I trial to study the effectiveness of combining liposomal doxorubicin with ifosfamide in treating patients who have advanced or metastatic soft tissue sarcoma.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of ifosfamide in combination with doxorubicin HCl liposome in patients with previously untreated advanced or metastatic soft tissue sarcoma.
- Determine the objective response in patients treated with this regimen.
- Determine the dose-limiting toxicity in patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of ifosfamide.
Patients receive doxorubicin HCl liposome IV over 1 hour on day 1 and ifosfamide IV over 4 hours on days 1-3 OR on days 1-4 (for patients enrolled on dose level 6). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of ifosfamide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed soft tissue sarcoma
- •Advanced and/or metastatic disease
- •Must be of any of the following types:
- •Malignant fibrous histiocytoma
- •Liposarcoma (excluding lipomas and well-differentiated liposarcomas)
- •Rhabdomyosarcoma
- •Synovial sarcoma
- •Malignant paraganglioma
- •Fibrosarcoma
- •Leiomyosarcoma
- •Angiosarcoma
- •Neurogenic sarcoma
- •Sarcoma not otherwise specified
- •Paraffin blocks and slides must be available
- •Measurable disease
- •Osseous lesions and pleural effusions are not considered measurable disease
- •Evidence of progressive disease within the past 6 weeks
- •The following conditions are excluded:
- •Gastrointestinal stromal tumors
- •Malignant mesothelioma
- •Chondrosarcoma
- •Neuroblastoma
- •Osteosarcoma
- •Ewing's sarcoma
- •Embryonal rhabdomyosarcoma
- •No symptomatic or known CNS metastases
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC at least 4,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.75 mg/dL
- •Albumin at least 2.5 g/dL
- •Creatinine no greater than 1.4 mg/dL
- •Creatinine clearance at least 65 mL/min
- •Cardiovascular:
- •Ejection fraction at least 50% by echocardiogram or isotopic methods
- •No history of cardiovascular disease
- •No other prior or concurrent primary malignancies except adequately treated carcinoma in situ of the cervix or basal cell carcinoma
- •No other severe medical illness
- •No psychosis
- •No psychological, familial, sociological, or geographical condition that would preclude study participation
- •Not pregnant
- •Fertile patients must use effective contraception (barrier method for men) during and for 6 months after study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
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排除标准
- 未提供