Phase II, Multicenter, Randomized, Open Label Study of a Sequential Treatment of Intermittent Erlotinib and Docetaxel Versus Erlotinib in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer After Failure of a Prior Chemotherapy Regimen
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 70
- 试验地点
- 8
- 主要终点
- Percentage of patients without disease progression after 6 months of treatment.
研究概览
简要总结
Erlotinib has demonstrated efficacy as a single agent in patients with NSCLC and the addition of erlotinib to chemotherapy has not achieved better results in the general population.
However, several preclinical and phase I studies have shown that a sequential treatment of erlotinib and chemotherapy could avoid a possible negative interaction between both drugs when administrated concomitantly, and therefore, it could improve the benefit of the combination therapy.
This study will investigate if the intermittent treatment of a chemotherapy drug, such as docetaxel, with erlotinib could achieve a clinical benefit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Written informed consent.
- •Age >= 18 years.
- •Histologically or cytologically documented inoperable, locally advanced (stage IIIb with malignant pleural or pericardial effusion) or metastatic (Stage IV) NSCLC.
- •Patients who have failed only one prior chemotherapy to treat the advanced disease and candidates to receive a second line treatment.
- •ECOG PS 0-
- •Adequate hematological function: hemoglobin => 9 g/dl; neutrophils count => 1.5 x 10(9)/l; platelet count => 100 x 10(9)/l.
- •Adequate liver function: Bilirubin <= 1,5 x ULN; AST and ALT <= x 3 ULN when no hepatic metastases or <=5 x ULN if hepatic metastases; Alkaline phosphatase <=5 x UNL except that there is hepatic metastases.
- •Adequate renal function: Calculated creatinine clearance => 40 mL/min (Cockroft y Gault) or serum creatinine <= 1.5 x ULN .
- •Patient able to meet the requirements of the study and accessible for correct follow-up.
- •Oral swallowing capability.
排除标准
- •Previous treated with more than one chemotherapeutic treatment for NSCLC
- •Concomitant treatment with another drug under investigation.
- •Pregnancy or lactation. Fertile women must provide a negative result of pregnancy test (in serum or urine) within 7 days prior to study treatment start. In addition, they must use an effective method of contraception (oral contraceptives, intrauterine device, barrier methods of contraception, together with spermicidal jelly or surgical sterilization) during the study.
- •Evidence of other disease, metabolic or neurological dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or patient at high risk from treatment complications.
- •Contraindication for the use of erlotinib or docetaxel.
研究组 & 干预措施
Docetaxel and Erlotinib
Patients in the experimental arm will receive sequential treatment of intermittent erlotinib and docetaxel up to 4 cycles in the absence of disease progression, unacceptable toxicity, patient refusal or investigator's decision to discontinue the treatment.
After 4 cycles, participants will receive 150 mg of erlotinib per day until disease progression, unacceptable toxicity, patient refusal or investigator's decision to discontinue the treatment.
干预措施: Docetaxel and Erlotinib (Drug)
Erlotinib
Erlotinib (Tarceva®) 150 mg/day po daily until disease progression, unacceptable toxicity, patient refusal or investigator's decision to discontinue the treatment.
干预措施: Erlotinib (Drug)
结局指标
主要结局
Percentage of patients without disease progression after 6 months of treatment.
时间窗: 6 months
次要结局
- Progression-free survival(Time from randomization until objective tumor progression or death for any cause. Tumour progression will be assessed every 2 months.)
- Overall Response Rate(The proportion of patients with tumor size reduction (complete response or partial response following RECIST criteria). Response will be assessed every 2 months.)
- Safety profile(Toxicity will be discribed per cycle and per patient according to CTCAE vs. 3, every 3 weeks.)
- Disease Control Rate(The proportion of patients without tumor size increase (complete response, partial response or stable disease following RECIST criteria). Response wil be assessed every 2 months.)
- Overall survival(Time from randomization until death from any cause. Follow up wil be assessed every 3 months after finishing study treatment.)
- Duration of Response(The time from the first complete response or partial response until objective tumor progression or death due to progression disease. Tumour progression will be assessed every 2 months.)