Study ID: NRG-GY019
Letrozole with or without paclitaxel and carboplatin in treating patients with ovarian or primary peritoneal cancer
This randomized phase 3 clinical trial is studying how well the FDA-approved oral medication letrozole, given with or without the chemotherapy drugs paclitaxel and carboplatin, works in treating patients with stage 2, 3 or 4 cancer of the ovary or peritoneum. Letrozole is currently approved for use in breast cancer. It lowers the amount of estrogen made by the body, and that, in turn, may stop the growth of tumor cells that need estrogen to grow.
It is not yet known whether giving letrozole alone or in combination with paclitaxel and carboplatin works better in treating patients with low-grade serous carcinoma of the ovary or peritoneum compared to paclitaxel and carboplatin without letrozole.
Eligible participants are divided into two study groups. One group receives paclitaxel, carboplatin and letrozole. The other group receives letrozole alone.
The primary objective of this randomized phase III study is to examine if letrozole monotherapy/maintenance is non-inferior to intravenous (IV) paclitaxel/carboplatin and maintenance letrozole with respect to progression-free survival in women with stage II-IV primary low-grade serous carcinoma of the ovary or peritoneum after primary surgical cytoreduction.
- Experimental Arm I (paclitaxel, carboplatin, letrozole): Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Cycles repeat every 21 days for up to 6 cycles. Patients then receive letrozole PO QD.
- Experimental Arm II (letrozole): Patients receive letrozole PO QD.
Eligible patients must have undergone an attempt at maximal upfront cytoreductive surgery, with either optimal (< 1 cm diameter residual disease/nodule) or suboptimal residual disease (> 1 cm diameter residual disease/nodule) status allowed. Patients must have undergone a bilateral salpingo-oophorectomy. Other inclusion/exclusion criteria apply.
- Must have been diagnosed with either stage 2, 3 or 4 cancer of the ovary or peritoneum
- Prior to trial enrollment, patients must have undergone surgical removal of both ovaries and the fallopian tube, and, at minimum, an attempt at surgical removal of their tumors
- Must not have concomitant invasive malignancy
- Must not have received prior chemotherapy or radiotherapy to treat their disease