Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00041314
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
2002-07-08
Brief Title:
Combination Chemotherapy in Treating Patients With Advanced Non-Small Cell Lung Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Phase II Trial Of Carboplatin And Gemcitabine With Exisulind In Patients With Advanced Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2023-06
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of carboplatin gemcitabine and exisulind in treating patients who have advanced non-small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of carboplatin gemcitabine and exisulind in treating patients who have advanced non-small cell lung cancer
Detailed Description:
OBJECTIVES
Determine the 18-month survival rate in patients with advanced non-small cell lung cancer treated with carboplatin gemcitabine and exisulind
Determine the feasibility and toxicity of this regimen in these patients
Determine the response rate progression-free survival and overall median survival of patients treated with this regimen
OUTLINE Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 1 Chemotherapy repeats every 21 days for up to 6 courses Patients also receive oral exisulind twice daily beginning on day 1 of course 1 and continuing until disease progression or unacceptable toxicity occurs
Patients are followed every 3 months for 2 years and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 55 patients will be accrued for this study within 6 months
Determine the 18-month survival rate in patients with advanced non-small cell lung cancer treated with carboplatin gemcitabine and exisulind
Determine the feasibility and toxicity of this regimen in these patients
Determine the response rate progression-free survival and overall median survival of patients treated with this regimen
OUTLINE Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 1 Chemotherapy repeats every 21 days for up to 6 courses Patients also receive oral exisulind twice daily beginning on day 1 of course 1 and continuing until disease progression or unacceptable toxicity occurs
Patients are followed every 3 months for 2 years and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 55 patients will be accrued for this study within 6 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| E-E1501 | None | None | None |