A randomised phase II study evaluating two schedules of the 21-day regimen of Gemcitabine and Carboplatin in advanced NSCLC
- Conditions
- on-small cell lung cancer
- Registration Number
- EUCTR2006-000744-17-BE
- Lead Sponsor
- niversity Hospital Ghent
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 64
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the haematological toxicity of the combination of Gemcitabine 1250 mg/m² d1, 8 and Carboplatin AUC 5 on d8 every 3 weeks and to compare this with Gemcitabine 1250 mg/m² on d1, 8 and Carboplatin AUC 5 on d1 every 3 weeks in patients with advanced non-small cell lung cancer. ;Secondary Objective: To compare response rate, non-hematologic toxicity and dose intensity profile of the two Gemcitabine-Carboplatin combinations in patients with advanced NSCLC. Side effects will be graded according to the Common Toxicity Criteria” defined by the NCI (US) and extended by the NCIC (Canada);Primary end point(s): The primary end-points of this phase II trial are:<br>1. Haematological toxicity<br>2. Response rates
- Secondary Outcome Measures
Name Time Method