A Phase II Clinical Trial Evaluating the Combination of Olaparib and Temozolomide for the Treatment of Advanced Uterine Leiomyosarcoma

Conditions

• Stage III Uterine Corpus Leiomyosarcoma AJCC v8
• Stage IV Uterine Corpus Leiomyosarcoma AJCC v8
• Uterine Corpus Leiomyosarcoma

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Computed Tomography — PROCEDURE
  Undergo CT
• Core Biopsy — PROCEDURE
  Undergo tumor biopsy
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Olaparib — DRUG
  Given PO
• Temozolomide — DRUG
  Given PO

Study Details

This phase II trial studies olaparib and temozolomide in treating patients with uterine leiomyosarcoma (LMS) that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced), that has spread from where it first started to other places in the body (metastatic) or cannot be removed by surgery (unresectable). PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as olaparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Chemotherapy drugs, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving olaparib and temozolomide may work better than giving either drug alone in treating patients with LMS.

Key Dates

Start date

Aug 19, 2019

Status verified

May 2026

Primary completion

Aug 1, 2020

Completion

Nov 12, 2026

Study Design

Enrollment

23 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (olaparib, temozolomide)
  Patients receive olaparib PO BID and temozolomide PO QD on days 1-7 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI throughout the trial and undergo tumor biopsy at screening and on study.

Primary Outcome Measure

Confirmed Objective Response Rate (ORR) (Complete Response + Partial Response) [ Time Frame: Within first 6 months of study treatment ]

Locations (15)

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