A Phase II Study of Docetaxel - Carboplatin as Second Line Treatment in Patients With Refractory or Relapsed Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
Phase II studies with docetaxel in first line - and second line treatment of SCLC demonstrated that docetaxel is an active agent in these patient groups. Therefore docetaxel seems suitable for evaluation in combination with other cytotoxic drugs active in this disease. A phase II study in previously untreated patients with SCLC shows that the combination docetaxel and cisplatin/carboplatin is an active and well tolerated regimen in extensive SCLC.
详细描述
Background:
Small cell lung cancer (SCLC) is diagnosed in approximately 15 % of all the lung cancer cases. SCLC is recognized by its rapid tumor growth, with a high chemo- and radio sensitivity, and by its high metastasizing potential. Patients with extensive-stage disease have a 5-year survival rate of 1% to 2%.
Almost 2/3 of the patients have already extensive disease (ED) upon diagnosis.The recommended treatment of ED-SCLC is systemic chemotherapy, considered to be the standard first line treatment option in all patients with SCLC regardless of performance status and age. World-wide, the most commonly used regimen for 1st line treatment is the combination of cisplatin-etoposide, while in the Netherlands the cyclophosphamide, doxorubicin and etoposide regimen is widely used.Survival outcome with these regimens appear similar.
Unfortunately, relapses occur in all patients and responses to second-line chemotherapy have proven to be of short term. Until recently, there were no registered drugs for treatment of relapsing SCLC. Phase II studies with docetaxel in first line - and second line treatment of SCLC demonstrated that docetaxel is an active agent in these patient groups. Therefore docetaxel seems suitable for evaluation in combination with other cytotoxic drugs active in this disease. Until now no studies have been performed with a combination of docetaxel and platinum in this group of previously treated SCLC patients.
A phase II study in previously untreated patients with SCLC shows that the combination docetaxel and cisplatin/carboplatin is an active and well tolerated regimen in extensive SCLC.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Histologically or cytologically proven SCLC at the first diagnosis
- •Refractory or relapsed SCLC
- •Measurable disease according to RECIST criteria
- •There must be a minimum of 2 weeks between the end of prior radiotherapy and study entry. (No more than 30% of available bone marrow should have been irradiated as recommended by the RTOG).
- •Patients must have fully recovered from toxic effects of previous antitumor therapy.
- •Age > 18 years.
- •WHO performance status 0- 2 (Appendix II).
- •Hb > 6.0 mmol/L,
- •Neutrophils > 1.5 x 109/L,
- •Platelets > 100 x 109/L·
- •Total bilirubin < the upper-normal limits of the institutional normal values.
- •ALAT (SGPT), ASAT (SGOT) < 2.5 times the upper-normal limits of the institutional normal values.
- •Alkaline Phosphatase < 5 times the upper-normal limits of the institutional normal values. If AP > 2.5 x ULN then ALAT and ASAT must be <1.5 x ULN, otherwise, the patient is not eligible
- •Creatinine < 140 mmol/L; or creatinine clearance according to Cockcroft formula >50 ml/min·
- •Signed informed consent prior to beginning protocol specific procedures
排除标准
- •More than one line of chemotherapy for metastatic disease
- •Treatment with a platinum compound during the last 3 months before randomisation
- •Pregnant or lactating women or women of childbearing potential not adhering to adequate anticonceptive measures
- •Evidence of (other) active invasive malignancy other than non-melanoma skin cancer.
- •Clinical evidence CNS metastases.
- •Symptomatic peripheral neuropathy > grade 2 according (NCI CTC, Appendix III)Definite contraindications for the use of corticosteroids
- •Concurrent treatment with other experimental drugs.
- •Participation in another clinical trial with any investigational drug within 30 days prior to study screening.
- •Concurrent treatment with any other cytotoxic anti-cancer therapy
研究组 & 干预措施
A
干预措施: Carboplatin, docetaxel (Drug)
结局指标
主要结局
Response rate
时间窗: 2 yrs
次要结局
- Time to progression; Response duration; Survival; Safety profile(2 yrs)