lung cancer
Conditions
Interventions
RAD001 in combination with standard radiotherapy.
Study treatments RAD001 (everolimus) combined with radiotherapy (66 Grays) and
followed by chemotherapy: dose escalation of RAD001 according to two r
Sponsors
Nederlands Kanker Instituut
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Unresectable non-small cell lung cancer, stage IIIA/B, or stage IV for which the primary tumor is symptomatic (cough, dyspnea, pain) without extra-thoracic lesions rapidly evolving 2) Measurable lesion, documented histologically, potentially accessible during fiberoptic bronchoscopy. 3) Age > 18 years, WHO 0-1, 4) Neutrophil count > 1500 /mm3, Hemoglobin > 9 g/dL, Platelet count > 100,000/mm3 5) Bilirubin 30 g / L, PT > 70% 6) Creatinine
Exclusion criteria
Exclusion criteria: 1) Patients previously treated with RAD001 (everolimus) or any other mTOR inhibitor 2) Stage IV for which the primary tumor is not symptomatic with extra-thoracic lesions rapidly evolving requiring systemic treatment 3) Previous radiotherapy, 4) Venous or arterial thrombosis, pulmonary embolism during the previous six months 5) Concomitant treatment with phenytoin, phenobarbital or any other antiepileptic agent, history of epilepsy 6) Concomitant treatment with medicinal products that inhibit, induce or are substrates for CYP3A4
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective: to evaluate the tolerability of the combination of RAD001 with radiotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objective(s) To determine the antitumor activity of the combination of RAD001 (EVEROLIMUS) and radiotherapy (CR+PR+SD). To determine the progression-free survival and the overall survival. | — |
Countries
Netherlands
Outcome results
None listed