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Study to Evaluate RAD001 in Combination With Radiotherapy in Non-small Cell Lung Cancer (RAD001)

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ClinicalTrials.gov Identifier: NCT01167530
Recruitment Status : Unknown
Verified July 2010 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was:  Recruiting
First Posted : July 22, 2010
Last Update Posted : April 4, 2012
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Locally Advanced Disease Drug: Everolimus Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2008
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : July 2014

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Everolimus
    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.


Primary Outcome Measures :
  1. Toxicity [ Time Frame: Eleven week ]
    Dose limiting toxicity


Secondary Outcome Measures :
  1. Progression-free and overall survival. [ Time Frame: Three years ]
  2. Response rate [ Time Frame: Four months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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).

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(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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01167530


Contacts
Contact: Eric DEUTSCH, MD 33 1 42114413 eric.deutsch@igr.fr
Contact: Jean-Pierre PIGNON, MD 33 1 42114565 jean-pierre.pignon@igr.fr

Locations
France
Institut Gustave Roussy Recruiting
Villejuif, France, 94800
Contact: Eric DEUTSCH, MD    33 1 42114413    eric.deutsch@igr.fr   
Contact: Jean-Pierr PIGNON, MD    33 1 42114565    jean-pierre.pignon@igr.fr   
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Novartis

Additional Information:
Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT01167530     History of Changes
Other Study ID Numbers: IGR 1269
First Posted: July 22, 2010    Key Record Dates
Last Update Posted: April 4, 2012
Last Verified: July 2010

Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris:
Everolimus
Radiotherapy
Chemotherapy

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents