NCT00181688已完成2 期
A Phase II Study of ZD1839 (Iressa) Plus Anastrozole (Arimidex) in Patients With Relapsed Ovarian Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 4
- 主要终点
- To define the median time to termination of treatment with Iressa and anastrozole in patients with asymptomatic relapsed ovarian cancer.
研究概览
简要总结
The main purpose of this study is to determine the effects (good and bad) Iressa plus anastrozole has on patients with relapsed ovarian cancer.
详细描述
- Patients will receive Iressa and anastrozole orally once daily until treatment is ended. Treatment will end if any of the following occur: Unacceptable adverse effects; bowel obstruction; initiation of systemic chemotherapy; development of new ascites or pleural effusions, development of co-morbid disease or disease progression.
- Patients will be given a drug log in which to record the date and time they take their pills, as well as any symptoms and concomitant medications.
- Patients will be seen monthly for the following tests and procedures; a physical examination and repeat blood work. Patients who remain free of clinical symptoms should have repeat abdominal/pelvic CT scans and chest x-rays on an every 3 month basis.
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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologic or cytologic history diagnosis of primary ovarian, primary peritoneal or tubal carcinoma
- •Asymptomatic from ovarian cancer
- •Evidence of recurrent ovarian, peritoneal or tubal carcinoma
- •Tumor sample must be positive for ER and/or PR
- •18 years of age or older
- •ECOG performance status of less than or equal to 1
- •Must be able to tolerate oral intake
排除标准
- •Known hypersensitivity to Iressa or any of the excipients of this product
- •Other coexisting malignancies or malignancies diagnosed within the last 5 years
- •Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital or St. John's wort
- •Treatment with a non-approved or investigational drug within 30 days
- •Any unresolved chronic toxicity greater than CTC grad 2 from previous anticancer therapy (except alopecia)
- •Incomplete healing from previous oncologic or other major surgery
- •Serum creatinine level greater than CTC grade 2
- •Pregnant or breast feeding
- •Severe uncontrolled systemic disease
- •Significant clinical disorder or laboratory finding that makes it potentially unsafe for the subject to participate
- •Patients currently receiving other investigational antineoplastic agents, on systemic chemotherapy or under radiation therapy treatment
- •Patients previously treated with anastrozole or other aromatase inhibitor
- •Unable to tolerate oral medications
- •Clinical and/or radiographic evidence of current or impending bowel obstruction
结局指标
主要结局
To define the median time to termination of treatment with Iressa and anastrozole in patients with asymptomatic relapsed ovarian cancer.
次要结局
- To define the median time to progression of this patient population
- to assess the tumor response and safety of this treatment.
研究者
Carolyn N. Krasner, MD
PI
Massachusetts General Hospital
研究点 (4)
Loading locations...
相似试验
已完成
1 期
ZD1839 With Hypofractionated Radiation Therapy With an Immobilization Device for Advanced Non-Small Cell Lung CancerNon-Small Cell Lung Carcinoma (NSCLC)NCT00328562Sidney Kimmel Cancer Center at Thomas Jefferson University13
已完成
2 期
Combination Casodex® and Iressa™ in Locally Advanced Prostate CancerLocally Advanced Prostate CancerNCT00319787AstraZeneca102
已完成
1 期
ZD 1839 Plus Combination Chemotherapy in Treating Patients With Locally Advanced, Locally Recurrent, or Metastatic Colorectal CancerColorectal CancerNCT00026364National Cancer Institute (NCI)22
已完成
1 期
ZD1839 (Iressa™) and Concurrent Chemo-Radiation in Patients With Locally Advanced Non Small Cell Lung CancerNon Small Cell Lung CarcinomaNCT00252798AstraZeneca44
撤回
2 期
Iressa and Radiotherapy in the Treatment of the Locally Advanced Inoperable Squamous Cell Carcinoma of the Head and NeckHead and Neck CancerCarcinoma, Squamous CellNCT00233636AstraZeneca28