DOXIL for Consolidation Therapy in Ovarian Cancer.
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|ClinicalTrials.gov Identifier: NCT00248248|
Recruitment Status : Completed
First Posted : November 3, 2005
Last Update Posted : October 12, 2011
The primary objective for this study is to evaluate the development, frequency and severity of hand foot syndrome (HFS) in ovarian cancer subjects treated with Doxil®, as consolidation therapy, on an every two week schedule.
The secondary objective for this study is to assess one-year progression free survival rate (PFS).
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Neoplasm||Drug: liposomal doxorubicin||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Non-randomized Study of DOXIL Consolidation Treatment for Ovarian Cancer, Cancer of the Fallopian Tube or Peritoneal Carcinoma.|
|Study Start Date :||October 2005|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||October 2011|
U.S. FDA Resources
Drug: liposomal doxorubicin
- Development, frequency, and severity of hand-foot syndrome with every two week therapy [ Time Frame: 5 years ]
- One-year progression free survival [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00248248
|United States, Georgia|
|Southeastern Gynecologic Oncology|
|Atlanta, Georgia, United States, 30342|
|Principal Investigator:||Jeffrey F Hines, MD, FACOG||Southeastern Gynecologic Oncology|