Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00198393
Status:
COMPLETED
Last Update Posted:
2010-04-30
First Post:
2005-09-13
Brief Title:
Randomized Phase 2 Study of 3 Therapeutic Modalities in PS 23 Patients With NSCLC Stage IIIBIV
Sponsor:
Intergroupe Francophone de Cancerologie Thoracique
Organization:
Intergroupe Francophone de Cancerologie Thoracique
Study Overview
Official Title:
Randomized Phase 2 Study of 3 Therapeutic Modalities in PS 23 Patients With NSCLC Stage IIIBIV
Status:
COMPLETED
Status Verified Date:
2010-04
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:
Patients presenting a deterioration of the general state performance status PS 2-3 constitute a population which needs an adapted treatment An analysis was made of the evolution of PS 2 patients included in the Eastern Cooperative Oncology Group ECOG 1594 trial which evaluated associations of new cytotoxic agents gemcitabine paclitaxel docetaxel with cisplatin During this trial the inclusion of these patients stopped due to the occurrence of toxicities more frequent than in the other populations PS 0-1 At the end of this study with the analysis of total toxicity this one was not higher than that noted in the groups of PS 0 and 1 patients In the population of PS 2 patients 5 deaths had been noted but the analysis showed that only 2 were due to the treatment It was noted that the lower survival compared to the others was related to the disease and not to the treatment These patients are often symptomatic and need palliative treatment The benefit of chemotherapy should not be denied They should profit from a monochemotherapy with the new cytotoxic agents without associated platinum salt
Detailed Description:
Arm A Iressa 250 mg daily PROGTOX -- Taxotere 75 mgm² d1 d1d22
Arm B Gemzar 1250 mgm² d1 d8 d1d22 PROGTOX -- Iressa 250 mg daily
Arm C Taxotere 75 mgm² d1 d1d22 PROGTOX -- Iressa 250 mg daily
Arm B Gemzar 1250 mgm² d1 d8 d1d22 PROGTOX -- Iressa 250 mg daily
Arm C Taxotere 75 mgm² d1 d1d22 PROGTOX -- Iressa 250 mg daily
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