Olaparib + Temozolomide for Uterine Leiomyosarcoma
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications that are strong or moderate CYP3A inhibitors or inducers. There is a required washout period (time without taking these medications) of 2 weeks for inhibitors and up to 5 weeks for some inducers before starting the study treatment.
What data supports the effectiveness of the drug combination Olaparib and Temozolomide for treating uterine leiomyosarcoma?
Research shows that the combination of Olaparib and Temozolomide was highly effective in preclinical studies for inhibiting tumor growth in uterine leiomyosarcoma, a type of aggressive cancer. Additionally, Olaparib has shown promising results in treating ovarian cancer, especially in patients with certain genetic mutations, suggesting its potential effectiveness in other cancers with similar characteristics.12345
Is Olaparib safe for use in humans?
What makes the drug combination of Olaparib and Temozolomide unique for treating uterine leiomyosarcoma?
The combination of Olaparib and Temozolomide is unique because it targets cancer cells in a novel way by combining a PARP inhibitor (Olaparib) with a chemotherapy agent (Temozolomide), potentially enhancing the effectiveness of treatment for uterine leiomyosarcoma, a condition with limited standard treatment options.7891011
Research Team
Brian Van Tine
Principal Investigator
Alliance for Clinical Trials in Oncology
Eligibility Criteria
This trial is for adults with advanced uterine leiomyosarcoma that has worsened after at least two prior treatments, including an anthracycline. Participants must have measurable disease, be in relatively good health (ECOG <=2), and women must test negative for pregnancy. Those with significant treatment-related side effects or who haven't recovered from previous therapies are excluded.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either olaparib plus temozolomide or investigator's choice of trabectedin or pazopanib. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment. Follow-up occurs every 6 weeks until disease progression, then every 3 months for the first 2 years, and every 6 months thereafter until 5 years post-randomization or death.
Treatment Details
Interventions
- Olaparib
- Temozolomide
Olaparib is already approved in European Union, United States for the following indications:
- Breast cancer
- Ovarian cancer
- Fallopian tube cancer
- Peritoneal cancer
- Pancreatic cancer
- Prostate cancer
- Endometrial cancer
- Ovarian, fallopian tube, and primary peritoneal cancer
- Breast cancer
- Prostate cancer
- Pancreatic cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor