Phase I Study of Concurrent Bevacizumab (Avastin) With Involved-field Thoracic Radiotherapy for Inoperable Non-squamous Non-small Cell Lung Cancer, Followed by Both Concurrent and Maintenance Bevacizumab
1. Cytologically or histologically confirmed stages II or III non-squamous NSCLC
2. No evidence of tumour invading major blood vessels and no active hemoptysis (bright
red blood of at least ½ teaspoon) in the 28 days prior to randomization.
3. No prior systemic therapy for NSCLC. Prior surgery and/or extra-thoracic irradiation
4. Presence of at least one measurable target lesion
5. Age 18 or greater.
6. WHO performance status of 0 or 1.
7. Acceptable pulmonary function as defined by a Fev1 of ≥30% and a DLCO of ≥40% of
8. Life expectancy of at least 12 weeks.
9. Adequate hematological, renal and hepatic functions
- Absolute neutrophil count >2x109/l.
- Platelet count > 100x109/l.
- Total bilirubin < 1.5 x UNL
- ASAT/ALAT < 2 x UNL
- Alkaline phosphatase < 5 x UNL
- Creatinine < 130 μmol/L
- Creatinine clearance > 60 ml/min; measured or calculated
10. Urine dipstick for proteinuria < 1+. If urine dipstick is ≥ 1, 24 hour urine must
demonstrate < 500 mg of protein in 24 hours.
11. No pre-existing sensory neurotoxicity grade 2 (CTC)
12. No active (uncontrolled) infection requiring antibiotics
1. Mixed tumor types with small cell lung cancer or squamous cell carcinoma
2. Other serious diseases, such as heart failure, angina pectoris, myocardial infarction
within the last 6 months, uncontrolled hypertension
3. Serious non-healing wound or ulcer.
4. ASAT and ALAT > 1,5 x UNL
5. alkaline phosphatase 5 x UNL
6. Evidence of bleeding diathesis or coagulopathy.
7. Any psychological, familial, sociological or geographical condition potentially
hampering compliance with the study protocol and follow-up schedule; those conditions
should be assessed with the patient before registration in the trial.
8. Participation in other trial with investigational drug or treatment modality.