A Single-arm, Phase II Clinical Trial of ASPIRin to prEvent Venous Thromboembolism in Patients With Advanced Germ Cell Tumors Receiving Chemotherapy
Summary
The purpose of this study is to the 6-month Venous Thromboembolism (VTE)-free rate in participants with advanced germ cell cancer at high risk of VTE who are receiving standard of care cisplatin-based chemotherapy and low-dose acetylsalicylic acid (ASA) and compare to relevant historical controls
Detailed description
This is a single-arm, two-stage, Phase II study designed to evaluate the 6-month VTE-free rate in participants with advanced germ cell cancer at high risk of VTE who are receiving standard of care cisplatin-based chemotherapy and low-dose ASA as compared to relevant historical controls. Stage 1 will consist of 13 participants. If at least 9 of those 13 do not experience a VTE event during the first 26 weeks on the ASA, Stage 2 will be activated. Stage 2 will enroll an additional 18 participants for a total of 31. Participants will provide their own supply of ASA. Participants will self-administer a fixed dose of ASA (81 mg) by mouth daily for 26 weeks. Participants who experience the primary endpoint of VTE will stop ASA and start standard of care anticoagulation at the direction of the treating investigator. This study will initially open as a single center study at Atrium Health Wake Forest Baptist Comprehensive Cancer Center (AHWFBCCC) and additional investigational site(s) may be added following activation at the lead site.
Arms & interventions
- DrugLow-dose ASA
81 mg by mouth daily for 26 weeks
Outcome measures
Primary
Venous thromboembolism (VTE)-free
A binary variable indicating whether the participant had zero VTE events within 26 weeks of initiation of standard chemotherapy. VTE events include objectively confirmed symptomatic or asymptomatic proximal deep-vein thrombosis in a lower limb, symptomatic deep-vein thrombosis in an upper limb or distal deep-vein thrombosis in a lower limb, symptomatic or incidental pulmonary embolism, symptomatic or incidental central catheter related thrombosis, or death from venous thromboembolism.
Time frame: 26 weeks after initiation of standard chemotherapy
Secondary
Major Bleeding Event
Time frame: 26 weeks after initiation of standard chemotherapy
Clinically Relevant Non-Major Bleeding
Time frame: 26 weeks after initiation of standard chemotherapy
Relapse-Free Survival (RFS)
Time frame: 2 years after initiation of standard chemotherapy
Overall Survival (OS)
Time frame: 2 years after initiation of standard chemotherapy
Eligibility criteria
Study locations (3)
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Charlotte, North Carolina, 28204
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
Aurora St. Luke's Medical Center MOB
Milwaukee, Wisconsin, 53215