Trial Information
Phase II Study Evaluating the Interest of the Re-introduction of Pemetrexed and Platinum (Cisplatin or Carboplatin) With Prolonged Angiogenic Blocking by Bevacizumab in Non Squamous Non Small Cell Lung Cancer of Advanced Stage.
Inclusion Criteria:
- Non squamous non small cell lung cancer histologically or cytologically confirmed
with no EGFR mutation.
- Stage IV NSCLC. Patient with cerebral metastasis are eligible if the metastasis is
asymptomatic.
- Measurable disease (recist criteria)
- Age ≥18 years
- PS0 or 1
Exclusion Criteria:
- Mixed cancer small cells and non small cells or squamous lung cancer . EGFR mutated
cancer
- History of malignant tumour excepted cervical and basocellular cancer and cancer
cured for at least 5 years.
- Tumor invaded the big vessels or the proximal visible in TDM.
- History of adjuvant or neoadjuvant chemotherapy
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Feasibility
Outcome Description:
Number of patients receiving 3 cycles of chemotherapy with full-dose platinum in the 2nd sequence
Outcome Time Frame:
After 3 cycles
Safety Issue:
Yes
Principal Investigator
Jaafar BENNOUNA, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Centre René Gauducheau - Nantes
Authority:
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study ID:
IFCT-1102
NCT ID:
NCT01705184
Start Date:
October 2012
Completion Date:
April 2014
Related Keywords:
- Non-small Cell Lung Cancer Metastatic
- Nonsquamous Nonsmall Cell Neoplasm of Lung
- Stop and go
- Non-small cell lung cancer
- Non-squamous
- Bevacizumab
- Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
- Neoplasms, Second Primary