Heated Chemotherapy and Niraparib for Ovarian, Peritoneal, and Fallopian Tube Cancer

Sponsor: GOG Foundation

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05659381

Provider View

This study is testing a treatment that combines heated chemotherapy with a drug called Niraparib for patients with ovarian, primary peritoneal, and fallopian tube cancer. The goal is to see if this approach can improve outcomes after surgery.

Patient Parameters

Program Overview

This clinical trial is exploring a treatment for ovarian, primary peritoneal, and fallopian tube cancer that involves using heated chemotherapy during surgery, followed by the drug Niraparib. Patients will first receive standard chemotherapy to shrink the cancer before surgery. During surgery, some patients will receive heated chemotherapy directly in the abdomen, while others will not. After surgery, all patients will continue with additional chemotherapy and then take Niraparib to help prevent the cancer from returning.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with high-grade serous or endometrioid ovarian, fallopian tube, or primary peritoneal cancer at stage III or IV.
  • Recommended for chemotherapy before surgery and considered suitable for surgery to remove as much cancer as possible.
  • For stage IV cancer, any cancer outside the abdomen must have responded well to initial treatment.
  • No visible cancer larger than 1 cm after surgery.
  • Must have specific genetic test results available.
  • Adequate blood cell counts and organ function.
  • Good overall health with a performance status of 0 or 1.
  • Aged 18 or older with a life expectancy of more than 3 months.
  • Women of childbearing potential must have a negative pregnancy test and use effective contraception during and after the study.
  • Normal or controlled blood pressure.
  • Stable dose of corticosteroids if applicable.
  • Agree not to donate blood during the study and for 90 days after.
  • HIV-positive patients can participate if they meet specific health criteria.

Exclusion Criteria

  • Have low-grade serous, clear cell, mucinous, non-epithelial ovarian cancers, or borderline tumors.
  • Have received other treatments for ovarian cancer besides initial chemotherapy.
  • Cancer has worsened during initial chemotherapy.
  • Medical conditions that make surgery unsafe.
  • Stage IV cancer that hasn't responded well to initial treatment.
  • History of certain blood disorders or leukemia.
  • Pregnant or breastfeeding.
  • Allergic to study drugs.
  • Severe infection requiring IV antibiotics recently.
  • Other uncontrolled medical conditions.
  • Cancer spread to the brain or spinal cord.
  • Uncontrolled diabetes or kidney issues.
  • Pre-existing hearing loss.
  • History of certain brain conditions.
  • Active liver or bile duct disease.
  • Significant digestive issues affecting absorption.
  • Serious heart conditions.
  • Increased risk of bleeding.
  • Active hepatitis B unless controlled.
  • Recent investigational therapy or live vaccine.
  • Recent diagnosis or treatment of another cancer.
  • Recent extensive radiation therapy.

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