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Study of Paclitaxel, Carboplatin, and Bevacizumab with Niraparib for Patients with Advanced Ovarian, Tubal, or Peritoneal Cancer After Surgery

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying treatments for patients with advanced ovarian cancer, which can also include primary peritoneal cancer and fallopian-tube cancer. The study involves two main treatments. The first treatment is a combination of chemotherapy drugs called paclitaxel and carboplatin, followed by a maintenance treatment with a medication called niraparib. The second treatment adds another medication called bevacizumab to the initial chemotherapy, followed by maintenance with both niraparib and bevacizumab. The purpose of the study is to determine which treatment approach is more effective in improving the time patients live without the cancer getting worse over a period of 24 months.

Participants in the study will receive one of the two treatment plans after undergoing a complete surgery to remove visible cancer. The study will begin with the chemotherapy phase, where patients will receive paclitaxel and carboplatin. In one group, patients will also receive bevacizumab during this phase. After the chemotherapy phase, patients will continue with a maintenance phase where they will receive niraparib, and in the second group, they will also continue with bevacizumab. The study will monitor patients over time to see how long they remain free from cancer progression and to assess the overall safety of the treatments.

The study aims to provide valuable information on whether adding bevacizumab to the treatment plan can improve outcomes for patients with advanced ovarian cancer. The trial will also look at other important factors such as the time until patients need further treatment and overall survival rates over five years. This research is important for understanding the best ways to treat these types of cancer and to improve the quality of life for patients.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including age, medical condition, and previous treatments.

    A signed informed consent is required, indicating understanding and agreement to participate in the study.

  2. Step 2

    Initial chemotherapy

    The initial treatment involves receiving one cycle of chemotherapy with carboplatin and paclitaxel.

    Carboplatin is administered at a dose calculated based on body surface area (AUC 5-6), and paclitaxel is given at 175 mg per square meter of body surface area.

  3. Step 3

    Second chemotherapy cycle

    The second cycle of chemotherapy begins, and bevacizumab is introduced.

    Bevacizumab is administered intravenously at a dose of 15 mg per kilogram of body weight every three weeks.

  4. Step 4

    Maintenance therapy

    Following the initial chemotherapy cycles, maintenance therapy starts.

    Niraparib is taken orally in the form of 100 mg hard capsules.

    Bevacizumab continues to be administered intravenously every three weeks, up to a total of 15 months.

  5. Step 5

    Monitoring and follow-up

    Regular monitoring is conducted to assess the progression-free survival rate and overall health status.

    Follow-up includes various assessments to evaluate the effectiveness and safety of the treatment.

Who can join the trial?

23 criteria

  • The patient must be a female who is at least 18 years old.
  • The patient should be eligible for bevacizumab treatment, which is a medication used with chemotherapy and for maintenance. It should start at the second chemotherapy cycle and be given every 3 weeks for up to 15 months.
  • The patient must have normal organ and bone marrow function before starting chemotherapy. This includes:
    • Hemoglobin level of at least 9.0 g/dL (a measure of red blood cells).
    • Absolute neutrophil count (ANC) of at least 1.5 x 109/L (a type of white blood cell).
    • Platelet count of at least 100 x 109/L (cells that help with blood clotting).
    • Total bilirubin level of 1.5 times the normal limit or less (a substance made by the liver).
    • Liver enzymes (ASAT/SGOT and ALAT/SGPT) should be 2.5 times the normal limit or less.
    • Serum creatinine level of 1.5 times the normal limit or less, and a glomerular filtration rate (GFR) greater than 50 mL/min (measures of kidney function).
    • The patient should not be on anticoagulant medication, or if they are, their blood clotting tests (INR and PTT/aPTT) should be within safe limits.
    • The patient should have a urine test showing proteinuria (protein in urine) less than 2+. If it is 2+ or more, a 24-hour urine test should show less than 1 gram of protein.
    • The patient should have normal blood pressure or controlled hypertension (high blood pressure), with readings of 140/90 mmHg or lower.
    • A sample of the patient's tumor, preserved in a specific way (FFPE), must be available for BRCA testing, and if possible, HRD testing (optional).
    • In certain countries, the patient must be affiliated with or a beneficiary of a social security category.
    • The patient must have signed an informed consent form and be able to follow the treatment and check-up schedule.
    • The patient should have a newly diagnosed case of:
      • Ovarian cancer, primary peritoneal cancer, or fallopian-tube cancer.
      • Confirmed by a pathologist as high-grade serous or high-grade endometrioid (grade 2 and 3) or other types of epithelial ovarian cancer, with a harmful mutation in the BRCA 1 or 2 genes.
      • At an advanced stage, specifically FIGO stage IIIA to IIIC.
      • The patient must have undergone a complete surgery to remove the cancer, with no visible disease left.
      • The patient should have an ECOG performance status of 0-1, which indicates they are fully active or have some symptoms but can carry out light work.
      • The patient must have received one cycle of chemotherapy with carboplatin and paclitaxel.
      • The first cycle of chemotherapy should have started no later than 6 weeks after surgery.
      • The patient must have had a CT scan of the chest, abdomen, and pelvis between surgery and the first cycle of chemotherapy, showing no evidence of disease.
      • The patient should be eligible for first-line chemotherapy with platinum-taxane drugs.

Who cannot join the trial?

3 criteria

  • Patients who do not have advanced ovarian, tubal, or peritoneal cancer cannot participate. This means the study is only for those with these specific types of cancer.
  • Only female patients are eligible. Male patients cannot participate in this study.
  • Patients who are considered part of a vulnerable population are not eligible. This typically refers to groups who may need special protection or care.
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Investigated drugs

  • Paclitaxel

    is a medication used in cancer treatment. It works by stopping the growth of cancer cells. In this trial, it is used in combination with other drugs to treat advanced ovarian cancer.

  • Carboplatin

    is a chemotherapy drug that helps to kill cancer cells. It is often used together with paclitaxel to enhance the effectiveness of the treatment for ovarian cancer.

  • Niraparib

    is a medication used as a maintenance therapy. It helps to keep the cancer from coming back after it has been treated. In this study, it is used after the initial treatment with paclitaxel and carboplatin.

  • Bevacizumab

    is a drug that works by blocking the blood supply to the cancer, which can slow its growth. In this trial, it is used both during the initial treatment phase and as part of the maintenance therapy along with niraparib.

What is already known about the treatment

  • Paclitaxel

    This medication is administered intravenously and is used in combination with other drugs for treating advanced ovarian, tubal, or peritoneal cancer. It is well-established in medical literature as a chemotherapy agent. Paclitaxel works by inhibiting cell division, which helps to stop the growth of cancer cells. It belongs to the pharmacological class of taxanes.

  • Carboplatin

    Administered intravenously, carboplatin is used alongside other medications to treat advanced ovarian, tubal, or peritoneal cancer. It is a well-known chemotherapy drug in medical practice. Carboplatin works by damaging the DNA of cancer cells, preventing them from dividing and growing. It is classified as a platinum-based chemotherapy agent.

  • Niraparib

    Taken orally, niraparib is used as a maintenance therapy for advanced ovarian, tubal, or peritoneal cancer. It is recognized in medical literature for its role in prolonging progression-free survival. Niraparib works by inhibiting the enzyme PARP, which helps repair DNA damage in cancer cells, leading to their death. It is classified as a PARP inhibitor.

  • Bevacizumab

    Administered intravenously, bevacizumab is used in combination with other drugs for treating advanced ovarian, tubal, or peritoneal cancer. It is well-documented in medical literature as an anti-cancer agent. Bevacizumab works by inhibiting the growth of blood vessels that supply nutrients to tumors, effectively starving the cancer cells. It belongs to the class of monoclonal antibodies.

Investigated diseases

  • Ovarian Cancer

    This is a type of cancer that begins in the ovaries, which are the female reproductive glands. It often goes undetected until it has spread within the pelvis and abdomen. In its advanced stages, it can cause symptoms such as abdominal bloating, pelvic pain, and changes in bowel habits. The disease progresses as cancer cells grow and potentially spread to other parts of the body. It is often diagnosed at a later stage due to subtle early symptoms. The progression can vary, with some cases advancing more rapidly than others.

  • Primary Peritoneal Cancer

    This cancer originates in the peritoneum, a thin layer of tissue lining the abdomen. It is closely related to ovarian cancer and shares many similarities in symptoms and progression. The disease can cause abdominal pain, bloating, and digestive issues as it advances. It often spreads within the abdominal cavity, affecting nearby organs. The progression is typically gradual, with symptoms becoming more pronounced over time. It is often detected at an advanced stage due to its subtle early signs.

  • Fallopian Tube Cancer

    This rare cancer starts in the fallopian tubes, which connect the ovaries to the uterus. It shares many characteristics with ovarian cancer, including similar symptoms such as pelvic pain and abnormal vaginal discharge. The disease progresses as cancer cells grow and may spread to nearby organs. It is often diagnosed at a later stage due to non-specific early symptoms. The progression can vary, with some cases advancing more quickly than others. It is closely monitored for changes in symptoms and spread.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504166-37-00Protocol codeGINECO-OV129bEstimated enrolment410 patientsSponsorArcagy Gineco

sourced from the EU Clinical Trials Register and site verification

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