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A092104: Testing olaparib and temozolomide versus the usual treatment for uterine leiomyosarcoma after chemotherapie

The purpose of this study is to compare an investigational treatment, olaparib and temozolomide, to the usual treatment for uterine leiomyosarcoma after two types of chemotherapy have stopped working

Age & Gender

  • 18 years ~ 99 years
  • Female

Visit Availability

  • Standard business hours (M-F, 8-5)
  • Visits can be combined with regular clinical appointments

Location

North Carolina (Statewide)

What will be asked of you

This study aims to treat your cancer and closely resembles routine care that would be received regardless of participating on a research study. To participate on the study, you will frequently meet with a member of the study team in addition to your oncology care team. The study also involves labs, Imaging (CT or MRI); physical exams; completion of questionnaires (paper surveys): before treatment begins; at the beginning of each cycle of treatment (until cycle 11); and after treatment ends. The study has 2 groups: a computer will be used to assign you to one of the groups (randomization). If you are in group 1: you will get the combination of olaparib and temozolomide. If you are in group 2: your will get trabectedin or pazopanib. After treatment, your doctor will continue to follow your condition for up to 5 years.

Incentives

In-person visits:
up to 13
Total length of participation:
Up to 5 years

Looking for Specific Volunteers

Able to participate:

  • you have uterine leiomyosarcoma
  • you are able to speak and/or read English and Spanish
  • your cancer has progressed on two prior treatments for your uterine leiomyosarcoma
  • you have not had treatment for your cancer within 28 days of study entry

Not eligible if:

  • you are pregnant or breastfeeding
  • you have had major surgery within 28 days of study entry
  • you have uncontrolled high blood pressure

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Linda Van Le
Obstetrics and Gynecology - Gynecologic Oncology

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Uterine (endometrial))

IRB Number

23-0817

ClinicalTrials.gov

NCT05633381

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