Study on Tazemetostat for Treating Recurrent Ovarian or Endometrial Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT03348631
This clinical trial is testing how well the drug tazemetostat works in treating ovarian or endometrial cancer that has returned after treatment. The study aims to see if tazemetostat can stop cancer cells from growing, dividing, or spreading.
Patient Parameters
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Program Overview
This phase II study is exploring the effectiveness of tazemetostat in patients with ovarian or endometrial cancer that has come back. Tazemetostat is a chemotherapy drug that may help stop the growth of cancer cells by killing them, preventing them from dividing, or stopping them from spreading.
Description
The main goals of this study are to see how well tazemetostat works in patients with recurrent or persistent ovarian or endometrial cancer, especially those with specific genetic mutations. Researchers will also look at the safety of the treatment and how long patients live without the cancer getting worse.
Patients will take tazemetostat by mouth twice a day in 28-day cycles, as long as the cancer does not progress and side effects are manageable. During the study, patients will have CT and MRI scans to monitor their cancer.
After finishing the treatment, patients will have follow-up visits every 3 months for 2 years, then every 6 months for 3 more years.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with recurrent or persistent ovarian or endometrial cancer, with specific types and genetic markers.
- Must have measurable cancer that can be tracked using scans.
- Have had 1 to 3 previous chemotherapy treatments for the cancer.
- Completed previous treatments, including chemotherapy, immunotherapy, and radiation, with enough time before starting this study.
- Be 18 years or older.
- Be in good overall health with a performance status score of 0, 1, or 2.
- Have adequate blood cell counts and organ function based on specific tests.
- Be able to swallow and absorb oral medications.
- Women of childbearing potential must use effective contraception during and after the study.
- Provide informed consent to participate in the study.
Exclusion Criteria
- Have previously been treated with an investigational EZH2 inhibitor.
- Have a history of certain blood cancers or genetic abnormalities.
- Have had recent procedures to remove fluid from the abdomen or chest.
- Have bowel obstruction or severe health conditions.
- Be pregnant or breastfeeding.
- Have HIV and are on antiretroviral therapy.
- Are taking certain medications that interact with tazemetostat.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Anchorage Associates in Radiation Medicine | 98508 | Anchorage | Alaska |
| Anchorage Radiation Therapy Center | 99504 | Anchorage | Alaska |
| Alaska Breast Care and Surgery LLC | 99508 | Anchorage | Alaska |
| Alaska Oncology and Hematology LLC | 99508 | Anchorage | Alaska |
| Alaska Women's Cancer Care | 99508 | Anchorage | Alaska |
| Anchorage Oncology Centre | 99508 | Anchorage | Alaska |
| Katmai Oncology Group | 99508 | Anchorage | Alaska |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| CTCA at Western Regional Medical Center | 85338 | Goodyear | Arizona |
| Kingman Regional Medical Center | 86401 | Kingman | Arizona |
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