Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00291850
Status:
TERMINATED
Last Update Posted:
2012-05-01
First Post:
2006-02-14
Brief Title:
Phase II Trial of Dose-dense Paclitaxel and Cisplatin as Neo-adjuvant Chemotherapy for Operable Stage II and IIA NSCLC
Sponsor:
Central European Cooperative Oncology Group
Organization:
Central European Cooperative Oncology Group
Study Overview
Official Title:
Phase II Trial of Dose-dense Paclitaxel and Cisplatin as Neo-adjuvant Chemotherapy for Operable Stage II and IIA Non-Small Cell Lung Cancer
Status:
TERMINATED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
no patient recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A single arm open-label phase II is appropriate to evaluate the efficacy and safety of dose - dense combination of paclitaxel with cisplatin supported by pegfilgrastim for neo-adjuvant chemotherapy in this patient population
Detailed Description:
This is an open-label single-arm Phase II study of dose-dense regimen with paclitaxel and cisplatin supported by pegfilgrastim as neo-adjuvant chemotherapy in patients with operable stage II IIA NSCLC
Paclitaxel will be administered via intravenous infusion over approximately 3 hours at dose of 175mgm2 on Day 1 of each 14-day cycle Cisplatin 75mgm2 will be given via intravenous infusion on day 1 after paclitaxel according to institutional guidelines
Pegfilgrastim Neulasta fixed dose of 6mg 06mL of a 10mgmL solution as a single subcutaneous injection on Day 2 of each study cycle
All drugs will be given in 2-weekly cycle Three cycles of pre-operative chemotherapy are planned
Paclitaxel will be administered via intravenous infusion over approximately 3 hours at dose of 175mgm2 on Day 1 of each 14-day cycle Cisplatin 75mgm2 will be given via intravenous infusion on day 1 after paclitaxel according to institutional guidelines
Pegfilgrastim Neulasta fixed dose of 6mg 06mL of a 10mgmL solution as a single subcutaneous injection on Day 2 of each study cycle
All drugs will be given in 2-weekly cycle Three cycles of pre-operative chemotherapy are planned
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