Informations générales (source: ClinicalTrials.gov)
Interventional
Phase 1
Gustave Roussy, Cancer Campus, Grand Paris (Voir sur ClinicalTrials)
mars 2008
juillet 2014
15 septembre 2025
The phase 1 study evaluats RAD001 in combination with radiotherapy in non-small cell lung
cancer.
First phase of the study:RAD001 (everolimus) will be administered per os every Monday,
one week before then during the radiotherapy and will be continued for 3.5 weeks after
the end of the radiotherapy. Chemotherapy is given 4.5 weeks after the end of
radiotherapy. Three patient cohorts are planned, receiving 10, 20 and 50 mg of RAD001 per
week.Second phase of the study:RAD001 (everolimus) will be administered per os every day
one week before then during the radiotherapy and will be continued for 3.5 weeks after
the end of radiotherapy. Chemotherapy is given 4.5 weeks after the end of radiotherapy.
Three patient cohorts are planned, receiving 2.5, 5 and 10 mg of RAD001 per day.The two
phases of the study may be conducted independently and in parallel.Radiotherapy: 66 Grays
over 6.5 weeks. (5 weekly fractions of 2 Grays)Chemotherapy: 2 cycles: Cisplatin 100
mg/m2 D1, Navelbine 25 mg/m2 D1, D8, every 21 days.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Eric DEUTSCH, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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 for which patients should receive radiotherapy at curative dose
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 < 1.5 mg/dL, Transaminases < 3 N, albumin >30 g / L, PT > 70%
6. Creatinine < 120 μM/L
7. Patient information and informed consent form signed.
8. No previous treatment for lung cancer (surgery, radiotherapy, chemotherapy).
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 for which patients should receive radiotherapy at curative dose
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 < 1.5 mg/dL, Transaminases < 3 N, albumin >30 g / L, PT > 70%
6. Creatinine < 120 μM/L
7. Patient information and informed consent form signed.
8. No previous treatment for lung cancer (surgery, radiotherapy, chemotherapy).
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(inhibitors: atazanavir, clarithromycin, indinavir, itraconazole,
ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin,
amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir,
verapamil, ciclosporin, voriconazoleinducers: rifampicin, carbamazepine,
rifabutinsubstrates: midazolam, buspirone, felodipine)
7. Concomitant therapy with agents otherwise used in the treatment of cancer (for
example methotrexate for rheumatoid arthritis).
8. Chronic treatment with corticosteroids or another immunosuppressant
9. Patients with an active bleeding diathesis or taking an oral vitamin K antagonist
(except low-dose Coumadin (warfarin sodium))
10. Other concurrent severe and/or uncontrolled disease which could compromise
participation in the study (i.e. uncontrolled diabetes, uncontrolled hypertension,
severe infection, severe malnutrition, unstable angina, or congestive heart failure
- New York Heart Association Class III or IV, ventricular arrhythmia, active
ischemic heart disease, myocardial infarction during the previous six months,
chronic liver or renal disease, active upper GI tract ulceration)
11. Impairment of gastrointestinal function or gastrointestinal disease that may
significantly alter the absorption of RAD001 (EVEROLIMUS) (i.e. ulcerative disease,
uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel
resection)
12. HIV seropositivity
13. Patient with a virological test positive to hepatitis B (HBs positive)
14. Patients with active cutaneous, mucosal, ocular or gastrointestinal disorders of
grade > 1
15. Previous cancer (except basal cell skin cancer or cervical carcinoma in situ) during
the 3 years prior to entering the trial.
16. important pulmonary fibrosis on X-ray
17. Women who are or could become pregnant or who are currently breastfeeding,