NCT00580320已完成1 期
Phase I Trial of Dacarbazine and Bortezomib in Melanoma and Soft Tissue Sarcoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Safety as measured by serious adverse events
研究概览
简要总结
Bortezomib will enhance the activity of dacarbazine against melanoma and soft tissue sarcoma. Weekly administration of the combination will prove to be feasible and tolerable at an appropriate dose.
详细描述
The primary objective is to determine recommended phase II doses for the combination dacarbazine and bortezomib administered weekly.
Secondary objectives are to determine the maximum tolerated dose combination and to observe anti-tumor activity in terms of response rate(s), duration of response, time to progression, and time on treatment (a measure of both antitumor activity and treatment tolerance).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic diagnosis of cutaneous or mucosal melanoma, soft tissue sarcoma (STS), or an APUD (amine precursor uptake and decarboxylation) tumor. APUD tumors include parathyroid carcinoma, medullary carcinoma of the thyroid, small cell carcinoma of the lung, pheochromocytoma, islet cell tumors, carcinoid tumors, and malignant paraganglioma.
- •Measurable or evaluable disease not appropriate for resection and/or radiation with curative intent. Patients with small cell carcinoma must have extended stage disease or, if limited stage disease, must have received at least one prior systemic therapy.
- •Age 18 years or greater
- •ECOG Performance Status 0 or 1
- •Women must be post-menopausal, infertile as the result of a surgical procedure, or willing to use a medically accepted form of birth control (abstinence, hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condon with spermicide) for the duration of study treatment. Men also must agree to use a medically accepted form of birth control for the duration of study treatment.
排除标准
- •Uncontrolled brain metastatic disease
- •Platelet count <100
- •Absolute neutrophil count <1.5
- •Blood transfusion or hematopoietic growth factors for cytopenia within one month of enrollment.
- •Calculated or measured (Cockcroft and Gault formula) creatinine clearance <30 mL/minute
- •AST > 3 times the upper limit of normal, unless elevation due to metastatic disease, in which case AST > 5 times the upper limit of normal
- •Bilirubin > 2 mg/mL
- •Grade 2 or greater peripheral neuropathy
- •Hypersensitivity to bortezomib, boron, mannitol, or dacarbazine
- •Pregnant or nursing
- •Other investigational drugs within 14 days of enrollment
- •Other medical or other condition(s) that in the opinion of the investigator/sub-investigator might compromise the objectives of the study
研究组 & 干预措施
A
Experimental
dacarbazine + bortezomib
干预措施: Dacarbazine and bortezomib (Drug)
结局指标
主要结局
Safety as measured by serious adverse events
时间窗: 4 years
次要结局
未报告次要终点
研究者
研究点 (2)
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