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Chemotherapy of Elderly Patients With Non-Small-Cell Lung Cancer (NSCLC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00298415
Recruitment Status : Completed
First Posted : March 2, 2006
Last Update Posted : October 25, 2013
Sponsor:
Information provided by (Responsible Party):
Intergroupe Francophone de Cancerologie Thoracique

Tracking Information
First Submitted Date  ICMJE March 1, 2006
First Posted Date  ICMJE March 2, 2006
Last Update Posted Date October 25, 2013
Study Start Date  ICMJE March 2006
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2008)
Overall survival [ Time Frame: 1-year ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 1, 2006)
Overall survival
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2008)
Objective response [ Time Frame: 2 cycles ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2006)
Objective response
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Chemotherapy of Elderly Patients With Non-Small-Cell Lung Cancer (NSCLC)
Official Title  ICMJE Phase III Study of Monotherapy by Gemcitabine or Vinorelbine Comparing to Doublet by Carboplatin and Paclitaxel Among Elderly Patients With Stage IIIB/IV NSCLC (Obligatory Second-line by Erlotinib)
Brief 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE NSCLC
Intervention  ICMJE
  • Drug: Paclitaxel + Carboplatin
    Paclitaxel 90 mg/m² D1, D8, D15 (D1=D29, 4 cycles) Carboplatin AUC 6 D1 (D1=D29, 4 cycles)
    Other Name: Treatment after progression : Erlotinib 150 mg/day
  • Drug: Monotherapy (gemcitabine or vinorelbine)
    Gemcitabine 1150 mg/m² D1 and D8 (D1=D22, 5 cycles) Vinorelbine 30 mg/m² D1 and D8 (D1=22, 5 cycles)
    Other Name: Treatment after progression : Erlotinib 150mg/day
Study Arms  ICMJE
  • Active Comparator: A
    Chemotherapy (mono)
    Intervention: Drug: Monotherapy (gemcitabine or vinorelbine)
  • Experimental: B
    Chemotherapy (doublet)
    Intervention: Drug: Paclitaxel + Carboplatin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 22, 2012)
451
Original Enrollment  ICMJE
 (submitted: March 1, 2006)
520
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pathologically / cytologically proven NSCLC stage IIIB or IV
  • age >= 70 years old and < 90 years old
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years to 89 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00298415
Other Study ID Numbers  ICMJE IFCT-0501
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Intergroupe Francophone de Cancerologie Thoracique
Study Sponsor  ICMJE Intergroupe Francophone de Cancerologie Thoracique
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Elisabeth QUOIX, Pr IFCT
PRS Account Intergroupe Francophone de Cancerologie Thoracique
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP