Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003449
Status:
COMPLETED
Last Update Posted:
2014-05-22
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Platinum-Resistant Recurrent Ovarian Cancer
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
Phase II Study of Weekly Paclitaxel and Gemcitabine in Platinum-Resistant Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2014-05
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 Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of dexamethasone plus paclitaxel and gemcitabine in treating patients with platinum-resistant recurrent ovarian cancer
PURPOSE Phase II trial to study the effectiveness of dexamethasone plus paclitaxel and gemcitabine in treating patients with platinum-resistant recurrent ovarian cancer
Detailed Description:
OBJECTIVES
Determine the response rate progression time and survival of patients with platinum-resistant ovarian cancer treated with weekly paclitaxel and gemcitabine
Determine the toxic effects of this regimen in these patients
Evaluate the toxic effects and safety profile of premedication with steroids with this regimen in these patients
OUTLINE Patients are stratified according to prior treatment with paclitaxel none or relapse more than 6 months after paclitaxel versus progressive disease or relapse less than 6 months after paclitaxel
Patients receive dexamethasone IV then paclitaxel IV followed by gemcitabine IV for 3 consecutive weeks on days 1 8 and 15 Treatment is continued every 4 weeks in the absence of disease progression or unacceptable toxicity
All patients are followed until death
PROJECTED ACCRUAL Approximately 18-35 patients will be accrued for this study
Determine the response rate progression time and survival of patients with platinum-resistant ovarian cancer treated with weekly paclitaxel and gemcitabine
Determine the toxic effects of this regimen in these patients
Evaluate the toxic effects and safety profile of premedication with steroids with this regimen in these patients
OUTLINE Patients are stratified according to prior treatment with paclitaxel none or relapse more than 6 months after paclitaxel versus progressive disease or relapse less than 6 months after paclitaxel
Patients receive dexamethasone IV then paclitaxel IV followed by gemcitabine IV for 3 consecutive weeks on days 1 8 and 15 Treatment is continued every 4 weeks in the absence of disease progression or unacceptable toxicity
All patients are followed until death
PROJECTED ACCRUAL Approximately 18-35 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 |
|---|---|---|---|
| LAC-USC-5O981 | None | None | None |
| NCI-G98-1460 | None | None | None |