Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003555
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
1999-11-01
Brief Title:
Paclitaxel Plus Chemoprotection With Amifostine in Treating Patients With Recurrent or Refractory Solid Tumors
Sponsor:
State University of New York - Upstate Medical University
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Use of Weekly One Hour Paclitaxel Infusion With Dose Escalation for Recurrent and Resistant Cancers Using Amifostine as a Cytoprotector
Status:
COMPLETED
Status Verified Date:
2006-05
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 Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy
PURPOSE Phase I trial to study the effectiveness of paclitaxel plus chemoprotection with amifostine in treating patients with recurrent or refractory solid tumors
PURPOSE Phase I trial to study the effectiveness of paclitaxel plus chemoprotection with amifostine in treating patients with recurrent or refractory solid tumors
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of weekly paclitaxel following amifostine in patients with recurrent or refractory solid tumors II Assess tumor response rate and survival in these patients
OUTLINE This is a dose escalation study of paclitaxel Patients receive amifostine IV over 5 minutes or less on day 0 followed by paclitaxel IV over 1 hour once a week for 6 weeks followed by 2 weeks of rest Patients with complete or partial response may receive additional courses of therapy Cohorts of 3-5 patients each receive increasing doses of paclitaxel The maximum tolerated dose is defined as the dose level prior to the cohort at which 1 of 3-5 patients experience dose limiting toxicity
PROJECTED ACCRUAL Approximately 20 patients will be accrued for this study
OUTLINE This is a dose escalation study of paclitaxel Patients receive amifostine IV over 5 minutes or less on day 0 followed by paclitaxel IV over 1 hour once a week for 6 weeks followed by 2 weeks of rest Patients with complete or partial response may receive additional courses of therapy Cohorts of 3-5 patients each receive increasing doses of paclitaxel The maximum tolerated dose is defined as the dose level prior to the cohort at which 1 of 3-5 patients experience dose limiting toxicity
PROJECTED ACCRUAL Approximately 20 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-V98-1463 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066614 | REGISTRY | None | None |
| ALZA-98-012-ii | None | None | None |