A Phase II Clinical Trial Evaluating the Combination of Olaparib and Temozolomide for the Treatme… (NCT03880019) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Phase II Clinical Trial Evaluating the Combination of Olaparib and Temozolomide for the Treatment of Advanced Uterine Leiomyosarcoma
United States23 participantsStarted 2019-08-19
Plain-language summary
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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* Patients must have histologically documented LMS of uterine origin. Pathology review and confirmation of diagnosis will occur at the site enrolling the patient on this study.
* Patients must have locally advanced and unresectable or metastatic disease.
* Patients must have disease which is measurable at study entry according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. Additionally, patients must have a site of disease deemed accessible for biopsy at no or minimal risk to the patient (including through the use of image-guidance). If there are questions regarding the feasibility of biopsy, the case should be reviewed with interventional radiology or the appropriate department at the study site prior to registration.
* Patients must have had prior progression on, or intolerance to, at least one line of systemic therapy for advanced LMS. Adjuvant therapy administered after curative resection will not qualify as prior treatment. There is no upper limit on the number of prior therapies received.
* Patients must be \>= 18 years of age. Uterine LMS affects older adults and is rarely encountered in children and adolescents.
* Patients must demonstrate an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of =\< 2 (Karnofsky \>= 50%).
* Absolute neutrophil count \>= 1,500/mcL (measured within 14 days prior to administration of study treatment).
* Hemoglobin \>= 9 g/dL (without transfusion of packed red blood cells…