Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003160
Status:
UNKNOWN
Last Update Posted:
2011-04-20
First Post:
1999-11-01
Brief Title:
Weekly Infusions of Paclitaxel in Treating Women With Stage III or Stage IV Ovarian Cancer Refractory to Paclitaxel and Platinum
Sponsor:
Theradex
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of Paclitaxel Taxol Administered as a Weekly One Hour Infusion in Patients With TaxolPlatinum-Refractory Stage III and IV Ovarian Cancer
Status:
UNKNOWN
Status Verified Date:
2001-01
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 Giving the drugs in different ways may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of paclitaxel in treating women with stage III or stage IV ovarian cancer that is refractory to paclitaxel and platinum-based regimens
PURPOSE Phase II trial to study the effectiveness of paclitaxel in treating women with stage III or stage IV ovarian cancer that is refractory to paclitaxel and platinum-based regimens
Detailed Description:
OBJECTIVES I Determine the objective response rate of paclitaxel given as a weekly one hour infusion in patients with paclitaxelplatinum refractory stage III and IV ovarian cancer II Evaluate the safety of paclitaxel in this patient population III Assess the overall survival in these patients IV Assess quality of life in these patients
OUTLINE This is a multicenter open label nonrandomized study Patients are administered paclitaxel as a one hour IV infusion every 7 days Each cycle consists of four weeks Treatment may be delayed for up to 2 weeks and there is no limit to the number of interruptions a patient may experience Patients receive paclitaxel weekly until disease progression or unacceptable toxicity Treatment is assessed every 3 cycles for one year and then every 6 months thereafter during study Quality of life is assessed every cycle for the first 6 cycles then every 3 cycles thereafter Patients are followed every 3 months for survival
PROJECTED ACCRUAL There will be 100 patients accrued into this study
OUTLINE This is a multicenter open label nonrandomized study Patients are administered paclitaxel as a one hour IV infusion every 7 days Each cycle consists of four weeks Treatment may be delayed for up to 2 weeks and there is no limit to the number of interruptions a patient may experience Patients receive paclitaxel weekly until disease progression or unacceptable toxicity Treatment is assessed every 3 cycles for one year and then every 6 months thereafter during study Quality of life is assessed every cycle for the first 6 cycles then every 3 cycles thereafter Patients are followed every 3 months for survival
PROJECTED ACCRUAL There will be 100 patients accrued into 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-V97-1366 | None | None | None |
| THERADEX-B97-3250 | None | None | None |
| BMS-TAXMEN03 | None | None | None |