Recruiting
Phase 2

Doxorubicin & Trabectedin

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT07076186

Conditions

Uterine Leiomyosarcoma

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Trabectedin

Doxorubicin Hydrochloride

Study Details

Brief summary:

To find out if receiving standard chemotherapy (doxorubicin and trabectedin) can extend the cancer-free survival of patients with Stage 1b/2 uterine leiomyosarcoma who had surgery that fully removed the tumor.

Conditions

Uterine Leiomyosarcoma

Study ID

NCT07076186

Start date

Oct 2, 2025

Status verified date

Aug, 2026

Completion date

Dec 2, 2029

Anticipated

Primary completion date

Dec 2, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 > 28 g/L
  • 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.

Study Design

Enrollment

48 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase II Single Arm Treatment with Doxorubicin and Trabectedin

Participants will receive treatment on an outpatient and standard of care basis

Interventions

Trabectedin

Given by IV Infusion

Doxorubicin Hydrochloride

Given by IV Infusion

Primary outcome measure

  • Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts and Locations

Central contacts

Elise Nassif Haddad, MD

(281) 460-0607efnassif@mdanderson.org

Locations

The University of Texas M. D. Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Elise Nassif Haddad, MD

281-460-0607efnassif@mdanderson.org

Principal Investigator:

Elise Nassif Haddad, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-08-20.