A Phase II Trial of ZD1839 (Iressa) in Patients With Nonresectable Adrenocortical Carcinoma (ACC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 8
- 主要终点
- The primary objective of this study is to measure the objective response rate by RECIST (radiographic) criteria of nonresectable adrenocortical cancer to ZD1839
研究概览
简要总结
The use of Iressa will result in a greater than 20% response rate in patients with nonresectable adrenocortical cancer who have previously been treated with one other form of systemic therapy (either Mitotane or chemotherapy).
详细描述
Adrenocortical carcinoma is a rare cancer with an incidence of 1.5 to 2 per million people in the United States. Surgery is the only potentially curative option. Current systemic therapy, either Mitotane or chemotherapy, typically gives response rates of 20% or less. This study is designed to see if the newer targeted therapy, Iressa, may be of benefit for patients with this fatal disease.
Patients with nonresectable adrenocortical cancer who have progressed on at least one other form of systemic therapy (Mitotane or chemotherapy) will be given Iressa 250 mg by mouth daily until disease progression. This is a standard two-stage Phase II clinical trial. Eighteen patients with measurable disease will be enrolled in the first stage. If there is at least one responder, then an additional nine patients with measurable disease will be enrolled for a total of 27 patients with measurable disease. Up to six patients without measurable disease may be enrolled at any point in this study. Iressa will be provided free for all study participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Subject must be able to provide informed consent
- •Subject must be 18 years of age or older
- •Subject must have histologically confirmed ACC by Department of Pathology at Dartmouth Hitchcock Medical Center
- •Subject must have inoperable disease
- •Subject must have received some form of systemic therapy prior to enrolling in the study
排除标准
- •known severe hypersensitivity to Iressa
- •other co-existing malignancies diagnosed within the last five years except basal cell cancer or cervical cancer in situ
- •any unresolved CTC grade 2 toxicity from previous anticancer therapy (except alopecia)
- •absolute neutrophil count less than 1.5 x 1,000,000,000 per liter
- •platelets less than 20 x 1,000,000,000 per liter
- •severe uncontrolled systemic disease
- •pregnancy\breastfeeding
- •women who are fertile and not willing to practice abstinence or contraception
- •use of phenytoin, carbamazepine, rifampicin, barbiturates, or St. John's Wort
- •treatment with a non-approved or investigational drug within 28 days before Day 1 of study treatment
- •prior use of ZD1839 (Iressa) or any other anti-EGFR therapies
结局指标
主要结局
The primary objective of this study is to measure the objective response rate by RECIST (radiographic) criteria of nonresectable adrenocortical cancer to ZD1839
次要结局
- Duration of response
- Adverse event profile
- Duration of survival
- Time to progression