Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00199758
Status:
COMPLETED
Last Update Posted:
2007-11-12
First Post:
2005-09-14
Brief Title:
Study of an Early Change of a Chemotherapeutic Doublet Versus Four Cycles of Chemotherapy in Advanced Non Small Cell Lung Cancer
Sponsor:
University Hospital Limoges
Organization:
University Hospital Limoges
Study Overview
Official Title:
A Randomized Phase II Trial of Early Change of a Chemotherapeutic Doublet Versus Four Cycles of Chemotherapy in Advanced Non Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2007-11
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 optimal strategy in advanced non small cell lung cancer with stable disease is not well known There is no published study assessing an early change of chemotherapeutic drugs in these patientsAccordingly we conduct this trial with the objective to improve the rate of objective responses by the switch to another doublet after 2 cycles of CDDP-gemcitabine association for patients with stable diseases SD
Detailed Description:
Patients with stage IV NSCLC and measurable disease are included in a randomized phase II trial comparing for patients with stable disease after 2 cycles of a platin P-gemcitabine doublet P d1 75 mgm2 gemcitabine 1 250 mgm2 d1 d8 every three weeks two subsequent cycles of this doublet arm A to a switch to another doublet arm B paclitaxel 100 mgm2 d1 d8 d15 gemcitabine 1 250 mgm2 d1 d8 every four weeksPlatin gemcitabine and paclitaxel are administered according nadir and pre-cycle haematologic evaluations with dose decrease if needed Response criteria are assessed with RECIST classification by the investigator panel
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