Randomized Open Label Study of Doxorubicin-based Chemotherapy Regimens, With and Without Sildenafil, With Exploratory Analysis of Intermediate Cardiac Markers
Definitive study of sildenafil enhancement of anthracycline anticancer effects and
cardioprotection would require a randomized, placebo-controlled trial involving large
numbers of patients and many years of follow-up. It is appropriate to demonstrate that
concurrent administration of sildenafil and doxorubicin is safe and tolerable. Second, in
definitive studies it might be helpful to incorporate early markers of cardiac injury in
order to gain early insight into cardioprotective effects, but there are no such established
markers. As a correlative study, multiple intermediate markers will be tested. In order to
investigate these candidate markers it is appropriate to study patients receiving
doxorubicin alone, as early markers of injury may not be apparent in patients treated with
the combination. In order to accomplish these two goals the trial is a randomized trial
involving a sildenafil/doxorubicin group and a doxorubicin group.
Interventional
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety of concurrent sildenafil with doxorubicin-based chemotherapy
Sildenafil will be administered at least 7 days prior to scheduled first dose of doxorubicin and continue daily dosing through 2 weeks after last doxorubicin dose. Multiple biomarkers as candidate early markers of anthracycline-induced cardiotoxicity will be tested.
25 months
Yes
Andrew S. Poklepovic, MD
Principal Investigator
Virginia Commonwealth University
United States: Institutional Review Board
MCC-13419
NCT01375699
August 2011
August 2017
Name | Location |
---|---|
Virginia Commonwealth University | Richmond, Virginia |