NCT00048087撤回2 期
A Phase II Study of ZD1839 (Iressa), Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor, in Combination With Docetaxel in Patients With Recurrent or Metastatic Advanced Non-Small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Patient Response Rate to Iressa/Docetaxel
研究概览
简要总结
Patients will receive 250 mg Iressa by mouth daily each day while on this study. Patients will also receive docetaxel 30 mg/m2 by by vein (IV) on day 1 weekly for the first 3 weeks of each course of therapy. A course of therapy is 4 weeks. Patients will not receive docetaxel during week 4. A maximum of 8 full cycles of docetaxel plus Iressa are planned. Patients may continue on daily Iressa until progressive disease and/or unacceptable toxicity.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed non-small cell lung cancer.
- •Measurable, evaluable disease outside of a radiation port.
- •ECOG performance status 0-
- •Adequate hematologic function as defined by an absolute neutrophil count >= 1,500/mm3, a platelet count >= 100,000/mm3, a WBC >= 3,000/ mm3, and a hemoglobin level of >= 9 g/dl.
- •One prior chemotherapy regimen. This may include chemoradiation treatment.
- •Disease progression or recurrence within 6 months of last dose of chemotherapy in first chemotherapy regimen.
- •At least a 2-week recovery from prior therapy toxicity.
- •Signed informed consent.
- •Prior CNS involvement by tumor are eligible if previously treated and clinically stable for two weeks after completion of treatment.
排除标准
- •Prior Iressa or other EGFR inhibiting agents
- •Prior docetaxel therapy
- •Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.
- •Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy.
- •Incomplete healing from previous oncologic or other major surgery.
- •Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, St John's Wort, anti-coagulants.
- •Absolute neutrophil counts less than 1500 x 109/liter (L) or platelets less than 100,000x 109/liter (L).
- •Serum bilirubin greater than 1.25 times the upper limit of reference range (ULRR).
- •In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease, (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease).
- •A serum creatinine >= 1.5 mg/dl and calculated creatinine clearance <= 60 cc/minute.
- •Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2.5 times the ULRR if no demonstrable liver metastases or greater than 5 times the ULRR in the presence of liver metastases.
- •Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial.
- •Pregnancy or breast feeding
- •The patient has uncontrolled seizure disorder, active neurological disease, or Grade >= 2 neuropathy
- •The patient has received any investigational agent(s) within 30 days of study entry.
- •The patient has signs and symptoms of keratoconjunctivitis sicca or incompletely treated eye infection.
研究组 & 干预措施
Iressa + Docetaxel
Experimental
干预措施: ZD1839 (Drug)
Iressa + Docetaxel
Experimental
干预措施: Docetaxel (Drug)
结局指标
主要结局
Patient Response Rate to Iressa/Docetaxel
时间窗: 4 weeks cycles
次要结局
未报告次要终点
研究者
研究点 (1)
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