Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004176
Status:
COMPLETED
Last Update Posted:
2013-05-16
First Post:
2000-01-21
Brief Title:
Amifostine Chemotherapy and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
A Phase II Evaluation of Ethyol as an Esophageal Mucosal Protectant in the Treatment of Limited Disease Small Cell Lung Cancer With Chemotherapy and Twice-Daily Radiation
Status:
COMPLETED
Status Verified Date:
2013-05
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 Radiation therapy uses high-energy x-rays to damage tumor cells 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 plus chemotherapy and radiation therapy in treating patients who have limited-stage small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of amifostine plus chemotherapy and radiation therapy in treating patients who have limited-stage small cell lung cancer
Detailed Description:
OBJECTIVES I Determine the incidence and duration of moderate and severe acute esophagitis in patients with limited stage small cell lung cancer treated with amifostine chemoprotection plus chemotherapy and radiotherapy II Determine the tumor response to this regimen in these patients
OUTLINE Course 1 Patients receive amifostine IV over 5 minutes daily followed by radiotherapy twice daily Monday through Friday for 3 weeks Patients receive cisplatin IV over 30-60 minutes on day 1 and etoposide IV over 1 hour on days 1 2 and 3 Courses 2-4 Patients receive amifostine over 15 minutes on day 1 followed by cisplatin IV over 30-60 minutes and etoposide IV over 1 hour every 3 weeks Patients are followed at 1 month then every 3 months until death
PROJECTED ACCRUAL Approximately 33 patients will be accrued for this study within 1-2 years
OUTLINE Course 1 Patients receive amifostine IV over 5 minutes daily followed by radiotherapy twice daily Monday through Friday for 3 weeks Patients receive cisplatin IV over 30-60 minutes on day 1 and etoposide IV over 1 hour on days 1 2 and 3 Courses 2-4 Patients receive amifostine over 15 minutes on day 1 followed by cisplatin IV over 30-60 minutes and etoposide IV over 1 hour every 3 weeks Patients are followed at 1 month then every 3 months until death
PROJECTED ACCRUAL Approximately 33 patients will be accrued for this study within 1-2 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 |
|---|---|---|---|
| NCI-V99-1559 | None | None | None |
| WU-98-0206 | None | None | None |
| ALZA-WU-98-0206 | None | None | None |