Adjuvant Doxorubicin and Trabectedin for the Treatment of Patients with Uterine Leiomyosarcoma

Inclusion Criteria

• Patients must have histologically confirmed uterine leiomyosarcoma
• Patients must have localized tumors, AJCC stages 1b to 3 according to the AJCC uterine sarcoma staging system (high risk of relapse population)
• Patients must have had complete surgical resection of tumor within 3 months prior to initiation of adjuvant chemotherapy, complete surgical resection includes at least a total hysterectomy
• Patients must have no evidence of residual disease, as proven by CT chest-abdomen-pelvic within 28 days before randomization (exclude potential metastatic patients)
• Patients must have no history of pelvic radiation (hematologic tolerance of chemotherapy is impaired by pelvic radiation)
• No prior chemotherapy for the treatment of the uterine leiomyosarcoma
• Age >= 18 years. Because no dosing or adverse event data are currently available on the use of doxorubicin in combination with trabectedin in patients <18 years of age, children are excluded from this study
• Eastern Cooperative Oncology Group (ECOG) performance status >= 2 (Karnofsky >= 60%,)
• Absolute neutrophil count >= 1,000/mcL
• Platelets >= 100,000/mcL
• Total bilirubin =< institutional upper limit of normal (ULN) (except patients with Gilbert's syndrome, who must have total bilirubin < 3.0 mg/dL)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])alanine aminotransferase ALT(serum glutamic pyruvic transaminase [SGPT]) =< institutional ULN
• estimate glomerular filtration rate (eGFR) (using 2021 Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]) >= 40mL/min/1.73m^2
• Albumin > 28 g/L
• Creatine phosphokinase (CPK) =< 2 institutional ULN
• No cardiac dysfunction as proven by left ventricular ejection fraction (LVEF) > 50%
• For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
• Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
• If patients have a history of human immunodeficiency virus (HIV)-infected , then they must be on effective anti-retroviral therapy with undetectable viral load within 6 months. Patients without a history of HIV are eligible for trial
• Patients with a prior or concurrent malignancy whose natural history or treatment does not interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

• Patients who are receiving any other investigational agents
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to doxorubicin or trabectedin or other agents used in study
• Patients with uncontrolled intercurrent illness per clinical judgment of the study principal investigator (PI) and/or treating physician
• Patients with psychiatric illness/social situations that would limit compliance with study requirements