Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00240097
Status:
COMPLETED
Last Update Posted:
2014-11-27
First Post:
2005-10-13
Brief Title:
Study of Sequential Topoisomerase IrinotecanOxaliplatin - Etoposide Carboplatin in Extensive Small Cell Lung Cancer SCLC
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Study of Sequential Topoisomerase IrinotecanOxaliplatin-EtoposideCarboplatin in Extensive SCLC
Status:
COMPLETED
Status Verified Date:
2014-11
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 primary objective of Part I of the study is to determine tumor response rate of sequential topoisomerase targeting with irinotecanoxaliplatin followed by etoposide carboplatin in chemotherapy-naïve patients with extensive small cell lung cancer The primary objective of Part II of the study is to determine the objective tumor response rate of irinotecanoxaliplatin in patients with either refractory disease or who have relapsed to first line chemotherapy or chemoradiotherapy
Detailed Description:
This is a Phase II open label study for either chemotherapy-naïve patients with extensive SCLC or patients who are refractory or have relapsed to 1st line therapy for SCLC The primary objective is to determine the objective response rate
This study consists of 2 parts
Part I - Chemotherapy-naïve patients with extensive SCLC
These patients will be treated with sequential topoisomerase targeting regimens Regimen A and B Regimen A consists of irinotecan and oxaliplatin IROX given on Day 1 and Neulasta administered on Day 2 Regimen B consists of etoposide and carboplatin given on Day 15etoposide will be given daily x 3and Neulasta on Day 18 Then Regimen A will be given again 3 weeks later The first re-evaluation for response will be performed 3 weeks after the second round of the sequential regimens
Schema of Part I
Regimen A 2 weeks Regimen B 3 weeks Regimen A 2 weeks Regimen B 3 weeks Re-Stage
The second re-evaluation for response will be performed 3 weeks after the fourth round of the sequential regimen At this point patients with stable disease will be observed those with either a partial or complete response will be treated with another round of sequential therapy Regimen A Regimen B if there is no evidence of unacceptable toxicity At the end 3 weeks after of the fifth round of chemotherapy patients will be re-evaluated for response and will be followed-up for recurrent disease every 8 weeks
Analysis of Top I and Top II levels in peripheral blood mononuclear cells will be performed in 10 patients of Part I
Evaluation of the expression of the ERCC genes ERCC1 ERCC2 and XPF will be performed in those patients in Part I with an adequate tumor specimen
Part II - Patients who have either refractory disease or have relapsed from 1st line therapy
These patients will be treated with Regimen A1 IROX at 3-week intervals Neulasta will be administered on Day 2 of each cycle The first re-evaluation for response will be performed 3 weeks after the 3rd cycle of Regimen A1 The second re-evaluation for response will be performed 3 weeks after the 6th cycle of Regimen A1 At this point patients with stable disease will be observed those with either a partial or complete response will be treated with two additional cycles of Regimen A1 if there is no evidence of unacceptable toxicity At the end 3 weeks after of the 8th cycle of Regimen A1 patients will be re-evaluated for response and will be followed-up for recurrent disease every 8 weeks
Schema of Part II
Regimen A1 3 weeks Regimen A1 3 weeks Regimen A1 3 weeks Re-Stage
This study consists of 2 parts
Part I - Chemotherapy-naïve patients with extensive SCLC
These patients will be treated with sequential topoisomerase targeting regimens Regimen A and B Regimen A consists of irinotecan and oxaliplatin IROX given on Day 1 and Neulasta administered on Day 2 Regimen B consists of etoposide and carboplatin given on Day 15etoposide will be given daily x 3and Neulasta on Day 18 Then Regimen A will be given again 3 weeks later The first re-evaluation for response will be performed 3 weeks after the second round of the sequential regimens
Schema of Part I
Regimen A 2 weeks Regimen B 3 weeks Regimen A 2 weeks Regimen B 3 weeks Re-Stage
The second re-evaluation for response will be performed 3 weeks after the fourth round of the sequential regimen At this point patients with stable disease will be observed those with either a partial or complete response will be treated with another round of sequential therapy Regimen A Regimen B if there is no evidence of unacceptable toxicity At the end 3 weeks after of the fifth round of chemotherapy patients will be re-evaluated for response and will be followed-up for recurrent disease every 8 weeks
Analysis of Top I and Top II levels in peripheral blood mononuclear cells will be performed in 10 patients of Part I
Evaluation of the expression of the ERCC genes ERCC1 ERCC2 and XPF will be performed in those patients in Part I with an adequate tumor specimen
Part II - Patients who have either refractory disease or have relapsed from 1st line therapy
These patients will be treated with Regimen A1 IROX at 3-week intervals Neulasta will be administered on Day 2 of each cycle The first re-evaluation for response will be performed 3 weeks after the 3rd cycle of Regimen A1 The second re-evaluation for response will be performed 3 weeks after the 6th cycle of Regimen A1 At this point patients with stable disease will be observed those with either a partial or complete response will be treated with two additional cycles of Regimen A1 if there is no evidence of unacceptable toxicity At the end 3 weeks after of the 8th cycle of Regimen A1 patients will be re-evaluated for response and will be followed-up for recurrent disease every 8 weeks
Schema of Part II
Regimen A1 3 weeks Regimen A1 3 weeks Regimen A1 3 weeks Re-Stage
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UAB 0421 | OTHER | institutional protocol study number | None |