Study on Heated Chemotherapy for Primary Ovarian Cancer Patients

Sponsor: Andrea Jewell

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03321188

Provider View

This clinical trial is exploring the use of heated chemotherapy during surgery to treat ovarian cancer. The study aims to determine if this approach allows for starting standard chemotherapy within 42 days after surgery.

Patient Parameters

Program Overview

This study is testing a treatment method called Heated Intraperitoneal Chemotherapy (HIPEC) for ovarian cancer. During surgery to remove as much of the cancer as possible, patients will receive a one-time heated chemotherapy treatment with cisplatin directly in the abdomen. This is followed by six cycles of standard chemotherapy with carboplatin and paclitaxel given as an outpatient.

Description

Heated Intraperitoneal Chemotherapy (HIPEC) is a treatment that involves delivering heated chemotherapy directly into the abdomen during surgery. This method allows for higher doses of chemotherapy to be used because it stays mostly in the abdominal area and doesn't enter the bloodstream as much. The heat itself can help kill cancer cells and allows the chemotherapy to penetrate deeper into the tumor.

Recent studies have shown that the risks associated with HIPEC have decreased significantly. A review of 694 patients treated between 2005 and 2011 showed a complication rate of 33% and a 30-day mortality rate of 2.3%, which is similar to other major abdominal surgeries.

A recent study tested the maximum safe dose of HIPEC with cisplatin in patients with recurrent ovarian cancer. The study found that a dose of 100 mg/m2 was safe, with no deaths or major safety concerns. All patients in the study were able to receive additional chemotherapy after surgery.

Previous research has shown that using chemotherapy directly in the abdomen, along with standard chemotherapy, can improve survival in patients with advanced ovarian cancer. The goal is to find a treatment that is effective but also tolerable for patients, allowing them to complete all six cycles of chemotherapy without stopping due to side effects.

Eligibility Criteria

Inclusion Criteria

  • Must be able to understand and sign a consent form.
  • Diagnosed with specific types of ovarian, fallopian tube, or primary peritoneal cancer at Stage 3B or 3C, with small remaining tumors after surgery.
  • Eligible cancer types include serous, endometrioid, mucinous, undifferentiated, clear cell, mixed epithelial, or unspecified adenocarcinoma.
  • No previous HIPEC treatment.
  • Planned surgery to remove as much cancer as possible. If all cancer cannot be removed during surgery, the patient will not continue in the study.
  • Age 18 or older.
  • Good overall health with a performance status score of 0 to 2.
  • Adequate organ and bone marrow function, as shown by specific blood tests.
  • Women of childbearing potential and their partners must agree to use effective birth control during the study and for 90 days after treatment.

Exclusion Criteria

  • Currently using or planning to use other experimental treatments.
  • Received chemotherapy or radiation within 4 weeks before the study and not fully recovered from side effects.
  • Have cancer that has spread outside the abdomen, such as to the lungs.
  • Diagnosed with borderline ovarian tumors or early-stage ovarian cancer treated only with surgery.
  • Have or had endometrial cancer unless it meets specific conditions.
  • Poor overall health with a performance status score of 3 or 4.
  • History of inflammatory bowel disease.
  • Allergic reactions to similar drugs used in the study.
  • Uncontrolled illnesses like active infections or heart problems.
  • Mental health or social issues that would prevent following the study requirements.
  • Pregnant or breastfeeding women, due to potential risks to the baby.

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