Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00024388
Status:
UNKNOWN
Last Update Posted:
2008-07-24
First Post:
2001-09-13
Brief Title:
Chemotherapy in Treating Patients With Metastatic Kidney Cancer
Sponsor:
Theradex
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Open-Label Study of Taxoprexin DHA-Paclitaxel Injection by 2-Hour Intravenous Infusion In Patients With Metastatic Locally Advanced or Unresectable Renal Cell Carcinoma
Status:
UNKNOWN
Status Verified Date:
2002-06
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
PURPOSE Phase II trial to study the effectiveness of DHA-paclitaxel in treating patients who have locally advanced metastatic or unresectable kidney cancer
PURPOSE Phase II trial to study the effectiveness of DHA-paclitaxel in treating patients who have locally advanced metastatic or unresectable kidney cancer
Detailed Description:
OBJECTIVES I Determine the tumor response rate duration of response and time to disease progression in patients with locally advanced metastatic or unresectable renal cell cancer treated with DHA-paclitaxel II Determine the overall survival of patients treated with this drug III Determine the toxicity profile of this drug in these patients IV Assess the quality of life of patients treated with this drug
OUTLINE This is a multicenter study Patients receive DHA-paclitaxel IV over 2 hours on day 1 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity Quality of life is assessed at baseline every 2 courses and at completion of treatment Patients are followed every 3 months
PROJECTED ACCRUAL A total of 21-50 patients will be accrued for this study
OUTLINE This is a multicenter study Patients receive DHA-paclitaxel IV over 2 hours on day 1 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity Quality of life is assessed at baseline every 2 courses and at completion of treatment Patients are followed every 3 months
PROJECTED ACCRUAL A total of 21-50 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 |
|---|---|---|---|
| PROTARGA-P01-00-07 | None | None | None |
| THERADEX-P01-00-07 | None | None | None |
| CCF-IRB-4046 | None | None | None |