Testing Olaparib and Temozolomide Versus the Usual Treatment for Uterine Leiomyosarcoma After Chemotherapy Has Stopped Working

Conditions

• Locally Advanced Uterine Corpus Leiomyosarcoma
• Metastatic Uterine Corpus Leiomyosarcoma
• Stage III Uterine Corpus Leiomyosarcoma AJCC v8
• Stage IV Uterine Corpus Leiomyosarcoma AJCC v8
• Unresectable Uterine Corpus Leiomyosarcoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo collection of blood samples
• Bone Scan — PROCEDURE
  Undergo bone scan
• Computed Tomography — PROCEDURE
  Undergo CT scan
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Multigated Acquisition Scan — PROCEDURE
  Undergo MUGA
• Olaparib — DRUG
  Given PO
• Pazopanib — DRUG
  Given PO
• Temozolomide — DRUG
  Given PO
• Trabectedin — DRUG
  Given IV
• Transthoracic Echocardiography Test — PROCEDURE
  Undergo TTE

Study Details

This phase II/III trial compares the effect of the combination treatment with olaparib and temozolomide to trabectedin or pazopanib (two of the most common chemotherapy drugs used as usual approach) in patients with uterine leiomyosarcoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) after initial chemotherapy has stopped working. The usual approach is defined as care most people get for advanced uterine leiomyosarcoma. Olaparib is a PARP inhibitor. PARP is a protein that helps repair damaged deoxyribonucleic acid (DNA). Blocking PARP may prevent tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Temozolomide is in a class of medications called alkylating agents. It works by slowing or stopping the growth of tumor cells in the body. The combination of olaparib and temozolomide may work better than the usual treatment in shrinking or stabilizing advanced uterine leiomyosarcoma after initial chemotherapy has stopped working.

Key Dates

Start date

Mar 30, 2023

Status verified

Jan 2026

Primary completion

Aug 13, 2024

Completion

Jan 30, 2027

Study Design

Enrollment

74 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1 (olaparib, temozolomide)
  Patients receive temozolomide PO QD on days 1-7 of each cycle and olaparib PO BID on days 1-7 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI and/or bone scans throughout the trial. Patients also undergo collection of blood samples throughout the trial.
• Active Comparator: Arm 2 (trabectedin, pazopanib)
  Patients receive trabectedin IV continuously over 24 hours on day 1 of each cycle or pazopanib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI and/or bone scans throughout the trial. Patients also undergo TTE or MUGA on study and as clinically indicated, as well as collection of blood samples throughout the trial.

Primary Outcome Measure

Progression Free Survival (PFS) (Phase II) [ Time Frame: Time between the date of randomization and the earliest of disease progression or death, assessed up to 1 year ]

Locations (144)

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