Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at UC Davis UCSF
Dates
study started
completion around
Principal Investigator
by Shahzad Siddique (ucdavis)Lee-May Chen (ucsf)

Description

Summary

This phase III trial studies how well letrozole with or without paclitaxel and carboplatin works in treating patients with stage II-IV low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum. Letrozole is an enzyme inhibitor that lowers the amount of estrogen made by the body which in turn may stop the growth of tumor cells that need estrogen to grow. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. 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, fallopian tube, or peritoneum compared to paclitaxel and carboplatin without letrozole.

Official 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

Details

Keywords

Low Grade Fallopian Tube Serous Adenocarcinoma, Ovarian Low Grade Serous Adenocarcinoma, Primary Peritoneal Low Grade Serous Adenocarcinoma, Stage II Fallopian Tube Cancer AJCC v8, Stage II Ovarian Cancer AJCC v8, Stage II Primary Peritoneal Cancer AJCC v8, Stage III Fallopian Tube Cancer AJCC v8, Stage III Ovarian Cancer AJCC v8, Stage III Primary Peritoneal Cancer AJCC v8, Stage IV Fallopian Tube Cancer AJCC v8, Stage IV Ovarian Cancer AJCC v8, Stage IV Primary Peritoneal Cancer AJCC v8, Adenocarcinoma, Ovarian Neoplasms, Ovarian Epithelial Carcinoma, Fallopian Tube Neoplasms, Peritoneal Neoplasms, Serous Cystadenocarcinoma, Paclitaxel, Carboplatin, Albumin-Bound Paclitaxel, Letrozole, Biopsy, Biospecimen Collection, Imaging Technique, paclitaxel, carboplatin, letrozole

Eligibility

Locations

Lead Scientists at University of California Health

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
NRG Oncology
ID
NCT04095364
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 450 study participants
Last Updated