A randomised phase II study evaluating two schedules of the 21-day regimen of Gemcitabine and Carboplatin in advanced NSCLC

niversity Hospital Ghent0 个研究点目标入组 64 人开始时间: 2006年3月1日最近更新: 2014年10月27日

适应症

试验速览

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•- Patients with histologically or cytological proven NSCLC, stage IIIB with malignant pleural fluid and/or involved supraclavicular lymph nodes or stage IV. All tumour extensions will be classified according to TNM atlas.
•- At least 1 one-dimensional measurable lesion.
•- Chemotherapy-naive patients.
•- WHO 0-1
•- Physically and mentally fit enough to receive Carboplatin Gemcitabine chemotherapy.
•- At the start of treatment:
•Hb > or = 6.0 mmol/l (9.66 g/dl)
•WBC > or = 3.0 x 109/l
•ANC > or = 1.5 x 109/l
•Platelets > or = 100 x 109/l
•Creatinine < or = 150 µmol/l (1.69 mg/dl)
•Creatinine clearance > or = 50 ml/min calculated according to Cockroft-Gault’s formula: (weight (kg) x (140-age)/k x creat (mmol/l where k=0.96 for female and k = 0.814 for male.
•- Age < or = 18 years
•- Cooperation of patients for treatment and follow-up should be anticipated.
•- adequate contraceptive therapy
•- No symptomatic CNS involvement; however brain CT-scanning is only indicated on suspicion
•- Written informed consent is required and will be obtained according to regulations followed in the individual participating institutions
•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) yes
•F.1.3.1 Number of subjects for this age range

•Patients with one or several of the following criteria are not eligible:
•- Weight loss of > 10 % body weight in the month prior to registration.
•- Other malignancies (previous or current), except adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell
•carcinoma of the skin, or if previous malignancy was more than 5 years prior and there are no signs of recurrence.
•- Pregnancy and/or breast feeding
•- Use of any investigational agent in the month before enrolment into the study.
•- Uncontrolled infections
•- Usage of haematological growth factors

发起方

niversity Hospital Ghent