Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003251
Status:
UNKNOWN
Last Update Posted:
2013-12-04
First Post:
1999-11-01
Brief Title:
Amifostine Plus Chemotherapy and Radiation Therapy in Treating Patients With Advanced Unresectable Head and Neck Cancer
Sponsor:
University of Illinois at Chicago
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Pilot Study of Amifostine and Concomitant Cisplatin Paclitaxel and Radiotherapy in Previously Irradiated Recurrent Head and Neck Cancer
Status:
UNKNOWN
Status Verified Date:
2000-06
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 Radiation therapy uses 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 III trial to study the effectiveness of amifostine plus cisplatin paclitaxel and radiation therapy in treating patients who have advanced unresectable head and neck cancer
PURPOSE Phase III trial to study the effectiveness of amifostine plus cisplatin paclitaxel and radiation therapy in treating patients who have advanced unresectable head and neck cancer
Detailed Description:
OBJECTIVES I Assess the efficacy and role of amifostine as a cytoprotection agent with concurrent chemoradiotherapy in advanced previously irradiated or metastatic head and neck cancer II Determine the toxicity and response to cisplatin paclitaxel and radiation therapy in these patients III Determine the toxicity of amifostine in these patients
OUTLINE This is an open label study Patients receive paclitaxel by continuous infusion on days 0-3 Amifostine IV is administered over 5 minutes on days 1-5 Radiation therapy is administered once daily on days 1-5 Cisplatin IV is administered on day 5 Patients receive no treatment on days 6-13 Treatment is repeated every 2 weeks for up to 7 courses in the absence of disease progression and unacceptable toxicity Patients are followed monthly during the first year every 2 months during the second year then every 3 months thereafter
PROJECTED ACCRUAL This study will accrue 16-46 patients
OUTLINE This is an open label study Patients receive paclitaxel by continuous infusion on days 0-3 Amifostine IV is administered over 5 minutes on days 1-5 Radiation therapy is administered once daily on days 1-5 Cisplatin IV is administered on day 5 Patients receive no treatment on days 6-13 Treatment is repeated every 2 weeks for up to 7 courses in the absence of disease progression and unacceptable toxicity Patients are followed monthly during the first year every 2 months during the second year then every 3 months thereafter
PROJECTED ACCRUAL This study will accrue 16-46 patients
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-V98-1389 | None | None | None |
| UIC-H-97-783 | None | None | None |
| ALZA-UIC-H-97-783 | None | None | None |