A phase II study of docetaxel/carboplatin as secondline treatment in patients with refractory or relapsed SCLC

Jeroen Bosch - Groot Ziekengasthuis0 个研究点开始时间: 2007年4月25日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Histologically 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. (NB: Irradiated site cannot be the only site to evaluate response. 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 antitumour 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 ?mol/L; or creatinin clearance according to Cockroft formula >50 ml/min
•Signed informed consent prior to beginning protocol specific procedures
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years)
•F.1.3.1 Number of subjects for this age range

•More than one line of chemotherapy for metastatic disease
•Pregnant or lactating women or women of childbearing potential not adhering to adequate anticonceptive measures
•History of other invasive malignancy within the last 5 years (other than non melanoma skin cancer or excised cervical carcinoma in situ).
•Clinical evidence CNS metastasis.

发起方

Jeroen Bosch - Groot Ziekengasthuis