A Phase III Study of Letrozole Alone or with Chemotherapy in Women with Low-Grade Serous Ovarian or Peritoneal Cancer

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Full Title

A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients with Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum (NRG-GY019) (CIRB)

Purpose

The usual approach for women newly diagnosed with low-grade serous ovarian or peritoneal cancer is treatment with surgery followed by chemotherapy drugs such as carboplatin and paclitaxel and hormonal therapy such as letrozole. In this study, researchers are comparing the effectiveness of therapy with carboplatin/paclitaxel/letrozole versus letrozole alone in these patients. The use of letrozole without chemotherapy may shrink or stabilize a cancer in the same way as chemotherapy, but without the added side effects of chemotherapy.

Letrozole is a drug called an aromatase inhibitor, which indirectly stops the body from producing estrogen. In this study, patients will be randomly assigned to receive either carboplatin/paclitaxel/letrozole or letrozole alone. Carboplatin and paclitaxel are given intravenously (by vein) and letrozole is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have newly diagnosed stage II-IV low-grade serous ovarian or peritoneal cancer.
  • Patients must have had cancer surgery that included removal of the ovaries and fallopian tubes within 8 weeks of entering the study.
  • Patients may not have received chemotherapy, radiation therapy, or hormonal therapy for their cancer.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for women age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Rachel Grisham at 646-888-4653.

Protocol

19-402

Phase

III

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators