Alliance A092104

Clinical Trial Title A randomized phase 2/3 study of olaparib plus temozolomide versus investigator’s choice for the treatment of patients with advanced uterine leiomyosarcoma after progression on prior chemotherapy
Trial Status Open to Enrollment
Start Date 04/17/2023
Location hospitals
Trial Type Cancer - Adult Oncology
Specific Condition Gynecology Cancer
Description This phase II/III trial compares the effect of the combination of olaparib and temozolomide to the usual treatment (trabectedin and pazopanib) for uterine leiomyosarcoma that has spread to other places in the body (advanced) after initial chemotherapy has stopped working. 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.
Eligibility Criteria

Eligibility Criteria

  • Age ≥ 18 years
  • ECOG Performance Status ≤ 2
  • Histologically confirmed leiomyosarcoma of uterine origin , as established by the site enrolling the patient on study. Central pathology review will not occur.
  • Metastatic or locally advanced and surgically unresectable disease, in the opinion of the treating investigator.
  • Patients must have at least one lesion that is measurable per RECIST v1.1 criteria to be eligible for the study.
  • Patients must have had prior progression on, or intolerance to, at least two prior lines of systemic therapy for advanced uLMS, one of which was an anthracycline (anthracycline monotherapy or combination). Adjuvant chemotherapy will qualify as a prior line of treatment. Endocrine treatment will not qualify as a prior line of treatment.
  • Patients may not have received prior treatment with any PARP inhibitor, temozolomide or dacarbazine (IV analogue of temozolomide).
  • Patients must have completed all prior anti-cancer treatment, including radiation, ≤ 28 days prior to registration.
  • Patients may not have undergone major surgery (related or unrelated to their cancer diagnosis) ≤ 28 days of registration. Subjects with clinically relevant ongoing complications from prior surgery are not eligible.

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.
IRB Number Central IRB
Notes Testing Olaparib and Temozolomide Versus the Usual Treatment for Uterine Leiomyosarcoma After Chemotherapy Has Stopped Working - Full Text View - ClinicalTrials.gov
Principal Investigator Mei Dong, MD
Contact Name Oncology Clinical Research
Contact Phone 503-413-8199
Contact Fax 503-413-6920
Contact E-Mail oncologyresearch@lhs.org