Chemotherapy of Elderly Patients With Non-Small-Cell Lung Cancer (NSCLC)
Condition: NSCLC
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      The last ASCO recommendations in 2003 for the treatment of a CBNPC of stage IIIB/IV of
      elderly people, are to manage a monochemotherapy. Paclitaxel in association with carboplatin
      is feasible in elderly patients and the retrospective analysis of two studies of the
      comparing SWOG, one this association with that of cisplatine and vinorelbine and the other
      cisplatine only with cisplatine and vinorelbine, showed among 117 the 70 years old patients
      and more, the absence of significant difference of survival and toxicity compared to the
      younger patients. The study recently published of Lilenbaum and Al shows that among patients
      with bad PS, association carboplatine and paclitaxel do better than the paclitaxel only. The
      paclitaxel managed in weekly form is likely of a better activity by exposing the cancerous
      cells in a repeated way with shorter intervals without allowing the emergence of resistant
      clones and by allowing an increase in the intensity of amount. This mode of administration
      appeared at the same time effective and tolerated very well among patients of more than 70
      years. The weekly association of carboplatin and paclitaxel was tested in phase II and showed
      a rate of response of 14% and one survival 1 year from 31% a randomized test (not dedicated
      to the old person) of phase II to 3 arms was led by Belani et al.. The best combination of
      carboplatine + paclitaxel weekly proved to be that associating paclitaxel 100mg/m² 3 weeks
      out of 4 and carboplatine AUC 6 in J1 with J1 = J29. A test of phase II dedicated the 70
      years old to patients and more was carried out in France taking again this association
      carboplatine (AUC 6) every 4 weeks and paclitaxel weekly (90 mg/m² J1, J8 and J15). This test
      having included 51 patients highlighted a median of 10,42 months survival (IC 95%:
      7,29-17,05)
    

Detailed description: 
      It thus seemed to us justified to compare a standard arm, the vinorelbine or the gemcitabine
      (with the choice of the center) in monotherapy with an experimental arm, association
      carboplatine + paclitaxel. To avoid skewing the results by the introduction of a second line
      to the choice of the investigator, we chose to force it. It is thus the erlotinib which in a
      recent test presented by the NCIC at the ASCO 2004 proved its effectiveness in second or
      third line at the same time in term of response but more especially survival compared to the
      purely palliative care.
    

Intervention name(s): Paclitaxel + Carboplatin; Monotherapy (gemcitabine or vinorelbine)
Intervention type(s): Drug; Drug
Intervention description(s): Paclitaxel 90 mg/m² D1, D8, D15 (D1=D29, 4 cycles) Carboplatin AUC 6 D1 (D1=D29, 4 cycles); Gemcitabine 1150 mg/m² D1 and D8 (D1=D22, 5 cycles) Vinorelbine 30 mg/m² D1 and D8 (D1=22, 5 cycles)
Other intervention name(s): Treatment after progression : Erlotinib 150 mg/day; Treatment after progression : Erlotinib 150mg/day
Intervention MeSH terms: Paclitaxel; Vinorelbine; Carboplatin; Gemcitabine; Erlotinib Hydrochloride
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: 2-years survival