Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025285
Status:
COMPLETED
Last Update Posted:
2021-09-09
First Post:
2001-10-11
Brief Title:
Combination Chemotherapy Plus Thalidomide in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Phase II Study of Carboplatin Irinotecan and Thalidomide in Patients With Advanced Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2021-09
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 Thalidomide may stop the growth of cancer by stopping blood flow to the tumor Combining thalidomide with chemotherapy may kill more tumor cells and be an effective treatment for stage IIIB or stage IV non-small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus thalidomide in treating patients who have stage IIIB or stage IV non-small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus thalidomide in treating patients who have stage IIIB or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES
Determine the response rate and duration of response in patients with stage IIIB or IV non-small cell lung cancer treated with carboplatin irinotecan and thalidomide
Determine the progression-free and overall survival of patients treated with this regimen
Evaluate the toxicity profile of this regimen in these patients
OUTLINE Patients receive carboplatin IV over 30 minutes on day 1 and irinotecan IV over 90 minutes on days 1 and 8 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients with stable or responsive disease receive up to 6 courses of therapy Patients also receive oral thalidomide once daily beginning on day 1 and continuing until disease progression
Patients are followed every 3 months until disease progression and then every 6 months thereafter
PROJECTED ACCRUAL A total of 39-70 patients will be accrued for this study within 14 months
Determine the response rate and duration of response in patients with stage IIIB or IV non-small cell lung cancer treated with carboplatin irinotecan and thalidomide
Determine the progression-free and overall survival of patients treated with this regimen
Evaluate the toxicity profile of this regimen in these patients
OUTLINE Patients receive carboplatin IV over 30 minutes on day 1 and irinotecan IV over 90 minutes on days 1 and 8 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients with stable or responsive disease receive up to 6 courses of therapy Patients also receive oral thalidomide once daily beginning on day 1 and continuing until disease progression
Patients are followed every 3 months until disease progression and then every 6 months thereafter
PROJECTED ACCRUAL A total of 39-70 patients will be accrued for this study within 14 months
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 |
|---|---|---|---|
| NCI-5293 | None | None | None |
| CCCWFU-62400 | None | None | None |