Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-29 @ 11:08 PM
Study NCT ID:
NCT00312650
Status:
TERMINATED
Last Update Posted:
2015-01-12
First Post:
2006-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Doxil and Gemcitabine in Recurrent Ovarian Cancer
Sponsor:
Women and Infants Hospital of Rhode Island
Organization:
Study Overview
Official Title:
A Phase II Study of Every 2 Week Doxil and Gemcitabine in Recurrent Ovarian Cancer
Status:
TERMINATED
Status Verified Date:
2015-01
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:
Standard treatment for recurrent ovarian cancer is chemotherapy with one or more drugs. One of these drugs, Doxil, can cause skin toxicity at the standard dosages. This study investigates using a lower dose given more frequently in combination with a second drug Gemcitabine.
Detailed Description:
This study will evaluate the toxicities of Doxil and Gemcitabine given on an every two week basis. Our hypothesis is that toxicity will be less than that with standard dosing without any negative effect on survival. Patients will also be evaluated with CT scans every 3 months. Toxicity will be assessed with every cycle of treatment. Treatment will continue until toxicity or signs of progression.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: