Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00298415
Status:
COMPLETED
Last Update Posted:
2013-10-25
First Post:
2006-03-01
Brief Title:
Chemotherapy of Elderly Patients With Non-Small-Cell Lung Cancer NSCLC
Sponsor:
Intergroupe Francophone de Cancerologie Thoracique
Organization:
Intergroupe Francophone de Cancerologie Thoracique
Study Overview
Official Title:
Phase III Study of Monotherapy by Gemcitabine or Vinorelbine Comparing to Doublet by Carboplatin and Paclitaxel Among Elderly Patients With Stage IIIBIV NSCLC Obligatory Second-line by Erlotinib
Status:
COMPLETED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The last ASCO recommendations in 2003 for the treatment of a CBNPC of stage IIIBIV 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 100mgm² 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 mgm² J1 J8 and J15 This test having included 51 patients highlighted a median of 1042 months survival IC 95 729-1705
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None