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 study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Jean Perrin Clermont Ferrand France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Institut Gustave Roussy Villejuif France
Azienda Ospedaliero Universitaria Careggi Florence Italy
Oncopole Claudius Regaud Toulouse France
Centr Georges Francois Leclerc Dijon France
Katholieke Universiteit te Leuven Leuven Belgium
Azienda Ospedaliero Universitaria Di Sassari Sassari Italy
Hospital Universitario De Navarra Pamplona Spain
CHU Grenoble Alpes La Tronche France
Hospital Jerez de la Frontera Jerez De La Frontera Spain

Other Sites

Site Name City Country Status
Institut De Cancerologie Strasbourg Europe STRASBOURG, Alsace France
Centre Henri Becquerel Rouen France
Hopitaux Universitaires Pitie Salpetriere Paris France
Hopital Prive Jean Mermoz Lyon France
Hospices Civils De Lyon Lyon France
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Centre Hospitalier De Cholet Cholet France
Fundacio Assistencial De Mutua De Terrassa Fpc Terrassa Spain
Hopital Prive Des Cotes D’armor Plerin France
Groupe hospitalier Diaconesses Croix Saint Simon Paris France
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
AZ Sint-Lucas & Volkskliniek Gent Belgium
Hospital Femme Mere Enfant Bron France
Hopital Tenon Paris France
Centre Hospitalier Universitaire d’Orléans Orléans France
Centre Hospitalier Universitaire De Montpellier Montpellier France
Universidade De Santiago De Compostela Santiago De Compostela Spain
Assistance Publique Hopitaux De Paris Paris France
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Centre Hospitalier Universitaire De Nimes Nimes France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Del Mar Barcelona Spain
Hospital Universitari Dexeus Grupo Quironsalud Barcelona Spain
Hospital San Pedro De Alcantara Caceres Spain
Union Mut Gestion Groupe Hosp Mutualiste De Grenoble Grenoble France
Institut Sainte Catherine Avignon France
Immobiliere De Nancy Nancy France
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Institut Godinot Reims France
Azienda Socio Sanitaria Territoriale Della Valtellina E Dell Alto Lario Sondrio Italy
Clinique Tivoli Ducos Bordeaux France
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Clinique Victor Hugo Le Mans France
Institut de Cancérologie de l’Ouest Saint-Herblain France
Centre Francois Baclesse Caen France
L’Hopital Prive Du Confluent Nantes France
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Hospital Universitario Virgen De La Victoria Malaga Spain
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Asrdftj Oeynpcsliwo Ufixbxfuaeuym Ctmkjdfyqcxn Daaqm Sjhlhs E Dhads Sahhlwm Dm Tikouk Turin Italy
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not yet recruiting
01.01.2022
France France
Recruiting
01.01.2022
Italy Italy
Recruiting
01.01.2022
Spain Spain
Recruiting
01.01.2022

Trial locations

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.

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 ID:
2023-504166-37-00
Protocol code:
GINECO-OV129b
NCT ID:
NCT05183984
Trial Phase:
Therapeutic exploratory (Phase II)

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