Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00243867
Status:
COMPLETED
Last Update Posted:
2018-01-26
First Post:
2005-10-21
Brief Title:
Taxoprexin Plus Carboplatin Treatment for Advanced Lung Cancer
Sponsor:
American Regent Inc
Organization:
American Regent Inc
Study Overview
Official Title:
A Phase III Randomized Study of Weekly Taxoprexin Plus Carboplatin Versus Paclitaxel Plus Carboplatin as First Line Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2018-01
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 primary objective of this trial is to compare the survival of patients with advanced non-small cell lung cancer NSCLC treated with weekly Taxoprexin in combination with carboplatin to those treated with paclitaxel plus carboplatin in a prospectively randomized trial In addition the response rate to each regimen response duration time to progression and time to treatment failure will be measured Toxicity will be evaluated and compared between the two groups
Detailed Description:
This is a randomized multicenter Phase III open-label study of weekly Taxoprexin in combination with every three 3 week carboplatin compared to paclitaxel plus carboplatin every three 3 weeks in patients with advanced non-small cell lung cancer NSCLC who have not received cytotoxic agents for advanced disease Patients may have been previously treated with immunological agents Patients will be randomized to receive Taxoprexin at a dose of 400 mgm2 intravenously by one 1-hour weekly infusion 56 weeks followed immediately by carboplatin AUC 4 on weeks one 1 and four 4 as a 30 minute intravenous infusion or paclitaxel 225mgm2 as a three 3 hour intravenous infusion followed immediately by carboplatin AUC 6 as a 30 minute intravenous infusion every three 3 weeks Patients will receive Taxoprexin and carboplatin infusions or paclitaxel and carboplatin infusions until progression of disease intolerable toxicity completion of six 6 treatment cycles of paclitaxel plus carboplatin or three 3 treatment cycles of Taxoprexin plus carboplatin refusal of continued treatment by the patient or Investigator decision
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