Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003583
Status:
UNKNOWN
Last Update Posted:
2013-12-04
First Post:
1999-11-01
Brief Title:
Amifostine to Prevent Side Effects in Patients Who Are Receiving Chemotherapy and Radiation Therapy for Limited-Stage Small Cell Lung Cancer
Sponsor:
University of Florida
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial Using Amifostine as a ChemoRadio Protective Agent in the Treatment of Limited Stage Small-Cell Lung Cancer
Status:
UNKNOWN
Status Verified Date:
2006-05
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Drugs such as amifostine may protect normal cells from the side effects of chemotherapy and radiation therapy
PURPOSE Phase II trial to study the effectiveness of amifostine to prevent side effects in patients who are receiving chemotherapy and radiation therapy for limited-stage small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of amifostine to prevent side effects in patients who are receiving chemotherapy and radiation therapy for limited-stage small cell lung cancer
Detailed Description:
OBJECTIVES I Evaluate the reduction in toxicities by combining amifostine with cisplatin etoposide and radiotherapy in patients with limited stage small cell lung cancer II Evaluate the response rate to this combination by these patients III Evaluate the overall survival of patients treated with this regimen
OUTLINE This is a multicenter study Patients receive cisplatin IV on day 1 and etoposide IV daily on days 1-3 This course is repeated every 3 weeks for a total for 4 courses Patients also receive concurrent radiotherapy 5 days per week for 55 weeks starting with the first course of chemotherapy Patients receive amifostine IV over 15 minutes 15-30 minutes prior to each dose of chemotherapy on days 1-3 Patients are followed at 6 and 12 weeks then every 3 months for 9 months every 6 months for 1 year and then until death
PROJECTED ACCRUAL There will be 20 patients accrued into this study
OUTLINE This is a multicenter study Patients receive cisplatin IV on day 1 and etoposide IV daily on days 1-3 This course is repeated every 3 weeks for a total for 4 courses Patients also receive concurrent radiotherapy 5 days per week for 55 weeks starting with the first course of chemotherapy Patients receive amifostine IV over 15 minutes 15-30 minutes prior to each dose of chemotherapy on days 1-3 Patients are followed at 6 and 12 weeks then every 3 months for 9 months every 6 months for 1 year and then until death
PROJECTED ACCRUAL There will be 20 patients accrued into 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 |
|---|---|---|---|
| NCI-V98-1475 | None | None | None |
| UF-G-97120405 | None | None | None |
| ALZA-97-033-ii | None | None | None |