VTE Prevention With Rivaroxaban in Genitourinary Cancer Patients Receiving Systemic Therapy

Launched by OTTAWA HOSPITAL RESEARCH INSTITUTE · Jun 16, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating whether a medication called rivaroxaban, which is a type of blood thinner, can help prevent blood clots in patients with genitourinary cancers (like bladder, kidney, or testicular cancer) who are receiving treatments such as chemotherapy or immunotherapy. Patients with these types of cancer are at a higher risk of developing blood clots, which can lead to serious complications. The researchers want to find out if using low doses of rivaroxaban is both safe and effective for these patients during their cancer treatment.

To be eligible for the trial, participants must be at least 18 years old and starting systemic therapy for active genitourinary cancer, with a treatment plan lasting at least eight weeks. However, those with certain health issues, such as severe bleeding problems or specific allergies, may not qualify. If you decide to take part in the study, you’ll receive close monitoring to ensure your safety while assessing the potential benefits of rivaroxaban in reducing the risk of blood clots during your cancer treatment. This trial is currently recruiting participants, and your involvement could help shape future treatments for others in similar situations.

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Eligibility criteria

• Inclusion Criteria:
• • Patients who are starting systemic therapy for active GU cancer (bladder, testis, ureter/renal pelvis, kidney, urethral, penile) except for prostate cancer.
• • Age ≥ 18
• • Eligible systemic therapies include chemotherapy, targeted therapies (tyrosine kinase inhibitors and antiangiogenic therapy), and immunotherapies.
• • Patients must be initiating systemic therapy with a minimum planned treatment duration of 8 weeks.
• Exclusion Criteria:
• • Anticoagulation (prophylactic or therapeutic dosing) required for another indication for entire duration of study
• • Known allergies to rivaroxaban
• • Concomitant use of dual antiplatelet therapy (two antiplatelet medications oncomitantly)
• • Ongoing refractory bleeding that may be exacerbated by rivaroxaban.
• • Concomitant use of strong inducers or inhibitors of CYP3A4 or glycoprotein-P (known interaction with rivaroxaban).
• • Severe renal insufficiency (Creatinine clearance \<30 mL/min (defined by Cockcroft-Gault))
• • Severe liver disease (e.g. acute clinical hepatitis, chronic active hepatitis, cirrhosis)
• • Thrombocytopenia \< 50 x 109/L
• • Life expectancy under 6 months.
• • Pregnancy (if child bearing age under 50 and sexually active, documentation of use of effective contraception or negative B- HCG is required)
• • Patient is breastfeeding or lactating
• * History of condition at increased bleeding risk including, but not limited to:
• • cerebral infarction (hemorrhagic or ischemic), active peptic ulcer disease with recent bleeding, spontaneous or acquired impairment of hemostasis in the previous 4 weeks.
• • Chronic hemorrhagic disorder
• • Inability to adhere to protocol or obtain consent.
• • Patients may be excluded from the study for other reasons, at the investigator's discretion.