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.
Overview
- Phase
- Phase 2
- Intervention
- Cisplatin
- Conditions
- Non-small Cell Lung Cancer Metastatic
- Sponsor
- Intergroupe Francophone de Cancerologie Thoracique
- Enrollment
- 120
- Locations
- 12
- Primary Endpoint
- Feasibility
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
At present, the treatment of non-squamous cell lung cancer is based on chemotherapy with platinum eventually associated with bevacizumab. A new treatment begins at progression.
In colo-rectal metastatic cancer, it was demonstrated that the first-line of treatment could be administered according to a stop and go strategy respecting therapeutic breaks between sequences of identical treatment. During these therapeutic breaks, a treatment of maintenance is possibly better than an absence of treatment. These plans benefit to the patients in terms of efficiency but also in terms of toxicity, in particular neurological.
The question is to know if this strategy is feasible in lung cancer.
Investigators
Eligibility Criteria
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
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
Arms & Interventions
BUCiL
Sequence 1 : 3 cycles of cisplatin-pemetrexed-bevacizumab, then maintenance by bevacizumab if disease control. If progression --\> Sequence 2 Sequence 2 : 3 cycles of cisplatin-pemetrexed-bevacizumab, then maintenance by bevacizumab-pemetrexed if disease control
Intervention: Cisplatin
BUCiL
Sequence 1 : 3 cycles of cisplatin-pemetrexed-bevacizumab, then maintenance by bevacizumab if disease control. If progression --\> Sequence 2 Sequence 2 : 3 cycles of cisplatin-pemetrexed-bevacizumab, then maintenance by bevacizumab-pemetrexed if disease control
Intervention: Bevacizumab
BUCiL
Sequence 1 : 3 cycles of cisplatin-pemetrexed-bevacizumab, then maintenance by bevacizumab if disease control. If progression --\> Sequence 2 Sequence 2 : 3 cycles of cisplatin-pemetrexed-bevacizumab, then maintenance by bevacizumab-pemetrexed if disease control
Intervention: Pemetrexed
Outcomes
Primary Outcomes
Feasibility
Time Frame: After 3 cycles
Number of patients receiving 3 cycles of chemotherapy with full-dose platinum in the 2nd sequence
Secondary Outcomes
- Control rate after the 2nd sequence(After 3 cycles)
- Response rate after the 1st sequence(After 3 cycles)
- Overall survival(12 months)
- Quality of life(During Sequence 2 : at the beginning and after 3 cycles)