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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT01167530
First received: July 21, 2010
Last updated: April 3, 2012
Last verified: July 2010
  Purpose

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 Intervention Phase
Non-small Cell Lung Cancer
Locally Advanced Disease
Drug: Everolimus
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

Primary Outcome Measures:
  • Toxicity [ Time Frame: Eleven week ] [ Designated as safety issue: Yes ]
    Dose limiting toxicity


Secondary Outcome Measures:
  • Progression-free and overall survival. [ Time Frame: Three years ] [ Designated as safety issue: No ]
  • Response rate [ Time Frame: Four months ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: March 2008
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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,
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT01167530     History of Changes
Other Study ID Numbers: IGR 1269
Study First Received: July 21, 2010
Last Updated: April 3, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on August 28, 2014