Thalidomide and Doxil® in Patients With Androgen Independent Prostate Cancer (AIPC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00307294|
Recruitment Status : Completed
First Posted : March 27, 2006
Results First Posted : February 12, 2016
Last Update Posted : November 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Thalidomide Drug: Doxil||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Thalidomide and Doxil® (Doxorubicin HCL Liposome Injection) in Patients With Androgen Independent Prostate Cancer (AIPC) With a Rising PSA While on Chemotherapy|
|Study Start Date :||March 2006|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
Experimental: thalidomide and doxil
Combination of Thalidomide and Doxil
100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg
Other Name: ThalomidDrug: Doxil
On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days
Other Name: doxorubicin liposome
- Response Rate [ Time Frame: 24 weeks ]The number of patients experiencing a response to treatment, per RECIST criteria / total number of patients evaluable for response.
- Best Overall PSA Response [ Time Frame: 4 weeks ]PSA response as stable disease or progressive disease, per Prostate-Specific Antigen Working Group criteria.
- Overall Survival [ Time Frame: 36 months ]
- Time to Progression [ Time Frame: Up to 18 months ]Time from start of treatment until the disease progression per RECIST criteria.
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): NCT00307294
|United States, Pennsylvania|
|Hillman Cancer Center|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Gurkamal S Chatta, MD||University of Pittsburgh|