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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
35
81 mg by mouth daily for 26 weeks
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Charlotte, North Carolina, United States
RECRUITINGWake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
RECRUITINGAurora St. Luke's Medical Center MOB
Milwaukee, Wisconsin, United States
NOT_YET_RECRUITINGVenous 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
Major Bleeding Event
A categorical variable indicating whether the participant experienced a major bleeding event within 26 weeks of initiation of standard chemotherapy. A major bleeding event is defined by the occurrence of at least one of the following. Bleeding associated with death. Overt bleeding and associated with a decrease from baseline in hemoglobin concentration by at least 2.0 g/L or with the need for transfusion of ≥ 2 units of whole blood or red cells. Bleeding in a critical area or organ such as retroperitoneal, intracranial, intraocular, intraspinal, intraarticular or pericardial, or intramuscular with compartment syndrome as determined by the investigator.
Time frame: 26 weeks after initiation of standard chemotherapy
Clinically Relevant Non-Major Bleeding
A categorical variable indicating whether the participant experienced clinically relevant non-major bleeding within 26 weeks of initiation of standard chemotherapy. Clinically relevant non-major bleeding is defined as bleeding that leads to a medical intervention, an unscheduled contact with provider, temporary cessation of oral anticoagulants or antiplatelet agent, discomfort for the participant (such as pain) or impairment of activities of daily living.
Time frame: 26 weeks after initiation of standard chemotherapy
Relapse-Free Survival (RFS)
Calculated from the date of enrollment to the date of first documented evidence of recurrent disease or death, whichever occurred first. For participants who have not relapsed, RFS will be censored at the last disease status assessment. Relapse will be determined by biopsy proven recurrent non-teratoma germ cell tumor, initiation of salvage chemotherapy, or rising tumor markers unequivocally.
Time frame: 2 years after initiation of standard chemotherapy
Overall Survival (OS)
Calculated from the date of enrollment to the date of death from any cause. Participants who are alive or lost to follow up at the time of the final analysis will be censored at the last known date they were alive.
Time frame: 2 years after initiation of standard chemotherapy
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