Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003193
Status:
COMPLETED
Last Update Posted:
2012-12-06
First Post:
1999-11-01
Brief Title:
Paclitaxel and Radiation Therapy Plus Chemoprotection With Amifostine in Treating Patients With Stage III or Stage IV Head and Neck Cancer
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Phase III Study of Escalating Doses of Taxol Used Concurrently With Ethyol and Accelerated Hyperfractionated Radiotherapy in the Treatment of Stage III and IV Carcinoma of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2012-12
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 cancer cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy
PURPOSE Phase III trial to study the effectiveness of paclitaxel and radiation therapy plus chemoprotection with amifostine in treating patients with stage III or stage IV head and neck cancer
PURPOSE Phase III trial to study the effectiveness of paclitaxel and radiation therapy plus chemoprotection with amifostine in treating patients with stage III or stage IV head and neck cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of paclitaxel with amifostine and radiotherapy in patients with stage III or IV head and neck cancer
Determine the toxic effects and complications of this regimen in terms of mucositis reduction in these patients
Determine the complete response rate and progression-free survival of patients treated with this regimen
Determine whether amifostine modulates the plasma pharmacokinetics of paclitaxel in these patients
OUTLINE This is a dose-escalation study of paclitaxel with and without amifostine
Patients receive paclitaxel IV on days 1 8 15 29 36 and 43 for a total of 3-6 doses Patients also undergo radiotherapy twice daily for 6 weeks except for days when paclitaxel is given
Cohorts of 2-5 patients receive escalating doses of paclitaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2-3 patients experience dose-limiting toxicity An additional 10 patients are treated at the MTD
After determination of the MTD for paclitaxel subsequent patients also receive amifostine IV over 15 minutes on days 1 8 29 and 36 and radiotherapy on days 2-5 and 30-33 Determination of the MTD for this drug combination is carried out as with paclitaxel alone
At 4 to 8 weeks after the last treatment of radiotherapy patients undergo CT scanning to determine response Patients with residual masses undergo neck dissection Patients with complete or partial response at the primary site are followed without surgery
Patients are followed every 6 months
PROJECTED ACCRUAL A maximum of 37 patients will be accrued for this study
Determine the maximum tolerated dose of paclitaxel with amifostine and radiotherapy in patients with stage III or IV head and neck cancer
Determine the toxic effects and complications of this regimen in terms of mucositis reduction in these patients
Determine the complete response rate and progression-free survival of patients treated with this regimen
Determine whether amifostine modulates the plasma pharmacokinetics of paclitaxel in these patients
OUTLINE This is a dose-escalation study of paclitaxel with and without amifostine
Patients receive paclitaxel IV on days 1 8 15 29 36 and 43 for a total of 3-6 doses Patients also undergo radiotherapy twice daily for 6 weeks except for days when paclitaxel is given
Cohorts of 2-5 patients receive escalating doses of paclitaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2-3 patients experience dose-limiting toxicity An additional 10 patients are treated at the MTD
After determination of the MTD for paclitaxel subsequent patients also receive amifostine IV over 15 minutes on days 1 8 29 and 36 and radiotherapy on days 2-5 and 30-33 Determination of the MTD for this drug combination is carried out as with paclitaxel alone
At 4 to 8 weeks after the last treatment of radiotherapy patients undergo CT scanning to determine response Patients with residual masses undergo neck dissection Patients with complete or partial response at the primary site are followed without surgery
Patients are followed every 6 months
PROJECTED ACCRUAL A maximum of 37 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 |
|---|---|---|---|
| NCI-V98-1384 | None | None | None |
| MGH-M7-20 | None | None | None |
| ALZA-97-024-ii | None | None | None |