Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00083161
Status:
COMPLETED
Last Update Posted:
2012-09-05
First Post:
2004-05-14
Brief Title:
Cisplatin Etoposide and Cyclophosphamide in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Sponsor:
Gundersen Lutheran Health System
Organization:
Gundersen Lutheran Health System
Study Overview
Official Title:
Pilot Study of a Combination of Standard EtoposideCisplatin and Metronomic Cyclophosphamide in Patients With Newly Diagnosed Extensive Stage Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2012-09
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 Drugs used in chemotherapy such as cisplatin etoposide and cyclophosphamide work in different ways to stop tumor cells from dividing so they stop growing or die Combining more than one chemotherapy drug may kill more tumor cells
PURPOSE This phase II trial is studying how well giving cisplatin etoposide and cyclophosphamide together works in treating patients with extensive-stage small cell lung cancer
PURPOSE This phase II trial is studying how well giving cisplatin etoposide and cyclophosphamide together works in treating patients with extensive-stage small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Determine the safety of cisplatin etoposide and cyclophosphamide in patients with extensive stage small cell lung cancer
Determine the effect of this regimen on circulating endothelial cells in the peripheral blood of these patients
Secondary
Determine progression-free survival tumor response rate and overall survival in patients treated with this regimen
OUTLINE This is a multicenter study
Induction therapy Patients receive cisplatin IV over 30 minutes-2 hours on day 1 etoposide IV over 1-2 hours on days 1-3 OR etoposide IV on day 1 and orally twice daily on days 2-3 and oral cyclophosphamide twice daily on days 8-19 Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
Maintenance therapy Patients receive oral cyclophosphamide twice daily in the absence of disease progression
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 10 patients will be accrued for this study
Primary
Determine the safety of cisplatin etoposide and cyclophosphamide in patients with extensive stage small cell lung cancer
Determine the effect of this regimen on circulating endothelial cells in the peripheral blood of these patients
Secondary
Determine progression-free survival tumor response rate and overall survival in patients treated with this regimen
OUTLINE This is a multicenter study
Induction therapy Patients receive cisplatin IV over 30 minutes-2 hours on day 1 etoposide IV over 1-2 hours on days 1-3 OR etoposide IV on day 1 and orally twice daily on days 2-3 and oral cyclophosphamide twice daily on days 8-19 Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
Maintenance therapy Patients receive oral cyclophosphamide twice daily in the absence of disease progression
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 10 patients will be accrued for this study
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 |
|---|---|---|---|
| GLO-03-06-06 | None | None | None |