Phase II Decentralized Pragmatic Trial of Adjuvant Doxorubicin - Trabectedin Chemotherapy in uLMS

Launched by M.D. ANDERSON CANCER CENTER · Jul 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a combination of two chemotherapy drugs, doxorubicin and trabectedin, given after surgery to women with a rare type of cancer called uterine leiomyosarcoma. The goal is to see how safe this treatment is and how well it works to prevent the cancer from coming back in patients who have had their tumors completely removed by surgery.

Women who might be eligible for this study are those 18 years or older who have a confirmed diagnosis of uterine leiomyosarcoma with tumors that have not spread to other parts of the body. To join, patients need to have had surgery that removed the entire tumor, including a hysterectomy, within the last three months. They should not have had any prior chemotherapy or pelvic radiation, and their overall health needs to be good enough to handle chemotherapy. Before starting treatment, participants will have scans to make sure there’s no remaining cancer. If they join the trial, they can expect to receive chemotherapy treatment and be closely monitored for any side effects or changes in their health. This study is not yet recruiting, but it aims to find better ways to help women with this rare cancer after surgery.

Gender

FEMALE

Eligibility criteria

• 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.
• • ECOG performance status ≤2 (Karnofsky ≥60%,).
• * Patients must have adequate organ and marrow function as defined below:
• • 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)
• • AST(SGOT)/ALT(SGPT) ≤2× institutional ULN
• • eGFR (using 2021 CKD-EPI) ≥40mL/min/1.73m2
• • Albumin \> 2.8mg/dL
• • CPK ≤2× institutional ULN
• • No cardiac dysfunction as proven by 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.
• • 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 PI and/or treating physician
• • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
• • Patients with psychiatric illness/social situations that would limit compliance with study requirements.