Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004264
Status:
UNKNOWN
Last Update Posted:
2013-12-04
First Post:
2000-01-28
Brief Title:
Docetaxel Cisplatin and Amifostine in Treating Patients With Advanced Non-small Cell Lung Cancer
Sponsor:
University of Wisconsin Madison
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Trial of Amifostine High-Dose Cisplatin and Docetaxel in Patients With Advanced Lung Cancer
Status:
UNKNOWN
Status Verified Date:
2000-08
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 Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy
PURPOSE Phase III trial to study the effectiveness of combining docetaxel cisplatin and amifostine in treating patients who have advanced non-small cell lung cancer that cannot be surgically removed
PURPOSE Phase III trial to study the effectiveness of combining docetaxel cisplatin and amifostine in treating patients who have advanced non-small cell lung cancer that cannot be surgically removed
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of docetaxel when combined with amifostine and high dose cisplatin in patients with advanced non-small cell lung cancer II Determine the response rate and survival of these patients treated with this regimen III Determine the tolerability of this regimen in these patients
OUTLINE This is a dose escalation multicenter study of docetaxel Patients receive amifostine IV over 15 minutes immediately followed by docetaxel IV over 1 hour followed at hour 2 by amifostine as above immediately followed by high dose cisplatin IV over 30 minutes Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity Cohorts of patients receive escalating doses of docetaxel until the maximum tolerated dose is determined
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study
OUTLINE This is a dose escalation multicenter study of docetaxel Patients receive amifostine IV over 15 minutes immediately followed by docetaxel IV over 1 hour followed at hour 2 by amifostine as above immediately followed by high dose cisplatin IV over 30 minutes Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity Cohorts of patients receive escalating doses of docetaxel until the maximum tolerated dose is determined
PROJECTED ACCRUAL A total of 15-30 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-G00-1668 | None | None | None |
| WCCC-CO-9653 | None | None | None |