Virtua Clinical Trials

NRG-GY019

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

Patients are asked to take part in this research study because they have low-grade serous carcinoma of the ovary or peritoneum.
The usual approach for patients who are not in a study is treatment with surgery followed by chemotherapy drugs including carboplatin and paclitaxel (FDA approved drugs) and hormone drugs including letrozole. These treatments can reduce symptoms and may stop the tumor from growing for a few months or longer. The usual approach is proven to help patients with this health condition live longer.
The purpose of this study is to compare the treatment of carboplatin/paclitaxel and letrozole hormonal therapy to letrozole alone. The use of the hormonal therapy drug, letrozole without chemotherapy may shrink or stabilize the cancer in the same way that chemotherapy also does, but without the added side effects of chemotherapy. Letrozole is a drug called an aromatase inhibitor, which indirectly stops the body from producing estrogen.
This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. In order to determine if the use of letrozole alone helps to improve treatment for women with low-grade serous ovarian or peritoneal cancer compared to combined chemotherapy and letrozole, half of women in this study will receive letrozole with paclitaxel/carboplatin and the other half will receive letrozole alone. The study doctors will be looking to see if the letrozole alone prolongs the time the cancer is in remission, or the duration of time alive after treatment.
Letrozole is approved by the FDA for breast cancer, but is not FDA approved for ovarian cancer and considered experimental in this setting.

Click Here for more information

Principle Investigator: Randolph Deger, M.D.

Clinical Trials for Ovarian