Study on Letrozole With or Without Paclitaxel and Carboplatin for Treating Stage II-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Sponsor: NRG Oncology

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04095364

Provider View

This clinical trial is exploring whether letrozole alone or combined with chemotherapy drugs paclitaxel and carboplatin is more effective in treating patients with stage II-IV low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum.

Patient Parameters

Program Overview

The purpose of this study is to determine if letrozole, a drug that lowers estrogen levels, can effectively treat low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum when used alone or in combination with chemotherapy drugs paclitaxel and carboplatin. These chemotherapy drugs work by stopping cancer cells from growing and spreading. The study aims to find out which treatment option is better for patients with this type of cancer.

Description

The main goal of this study is to see if taking letrozole alone is as effective as taking it with chemotherapy drugs paclitaxel and carboplatin in preventing cancer from getting worse in women with stage II-IV low-grade serous carcinoma of the ovary or peritoneum after surgery.

Secondary goals include comparing the side effects of each treatment, how well the cancer responds to the treatments, overall survival rates, and how well patients stick to taking letrozole as prescribed.

Participants are randomly assigned to one of two groups:

  • Group 1: Receives paclitaxel and carboplatin through an IV every 21 days for up to 6 cycles, followed by daily letrozole pills if the cancer does not progress or cause unacceptable side effects. Blood samples and tumor biopsies are taken during screening, and medical imaging is done throughout the study.

  • Group 2: Takes letrozole pills daily every 21 days for up to 6 cycles, continuing with daily letrozole if the cancer does not progress or cause unacceptable side effects. Blood samples and tumor biopsies are taken during screening, and medical imaging is done throughout the study.

After completing the study treatment, participants are followed up every 3 months for 1 year, then every 6 months for 3 years, and annually thereafter.

Eligibility Criteria

Inclusion Criteria

  • Newly diagnosed with stage II-IV low-grade serous ovarian cancer, including fallopian tube and primary peritoneal cancers.
  • Patients with a history of serous borderline tumors but now diagnosed with stage II-IV low-grade serous ovarian cancer are eligible.
  • Must have a specific test result showing a normal p53 pattern.
  • Must have had a thorough medical exam and tumor assessment before joining the study.
  • Age 18 or older.
  • Must have had surgery to remove as much of the cancer as possible.
  • Must have had both ovaries and fallopian tubes removed.
  • Must be in good overall health with an ECOG performance status of 0, 1, or 2.
  • Must be within 8 weeks of surgery when starting the study.
  • Must be able to take oral medications.
  • Must have certain blood counts and organ function levels within normal limits.
  • Must provide informed consent and agree to the release of personal health information if in the U.S.
  • Patients with other cancers that do not interfere with this study are eligible.

Exclusion Criteria

  • Cannot have received chemotherapy or radiotherapy for this cancer before.
  • Cannot have had hormonal therapy for this cancer before.
  • Cannot have allergies to letrozole or intolerance to carboplatin/paclitaxel.
  • Cannot have severe heart disease, such as recent heart attack or severe heart failure.
  • Cannot have cancer that has spread to the brain.
  • Cannot have active or uncontrolled infections, except simple urinary tract infections.
  • Cannot have severe nerve damage.
  • HIV-positive patients on effective treatment with undetectable viral load are eligible.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.