Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00041054
Status:
COMPLETED
Last Update Posted:
2016-12-07
First Post:
2002-07-08
Brief Title:
Combination Chemotherapy and Exisulind in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase II Study of Carboplatin Etoposide and Exisulind in Patients With Extensive Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2016-12
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 Exisulind may make tumor cells more sensitive to chemotherapy Combining chemotherapy with exisulind may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining chemotherapy with exisulind in treating patients who have extensive-stage small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of combining chemotherapy with exisulind in treating patients who have extensive-stage small cell lung cancer
Detailed Description:
OBJECTIVES
Determine the percentage of patients with extensive stage small cell lung cancer who live more than 12 months after treatment with carboplatin etoposide and exisulind
Determine the response rate of patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive carboplatin IV over 30 minutes on day 1 and etoposide IV over 30-60 minutes on days 1-3 Patients also receive oral exisulind twice daily on days 1-21 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months for 1 year and then every 4 months for 2 years
Determine the percentage of patients with extensive stage small cell lung cancer who live more than 12 months after treatment with carboplatin etoposide and exisulind
Determine the response rate of patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive carboplatin IV over 30 minutes on day 1 and etoposide IV over 30-60 minutes on days 1-3 Patients also receive oral exisulind twice daily on days 1-21 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months for 1 year and then every 4 months for 2 years
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 |
|---|---|---|---|
| CDR0000069439 | REGISTRY | NCI Physician Data Query | None |
| CLB-30104 | None | None | None |