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Study on Adjusting Chemotherapy with Carboplatin and Paclitaxel for Patients with Poor Prognostic Ovarian Cancer

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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 ovarian cancer, specifically in patients who have a poor prognosis due to the cancer's resistance to initial chemotherapy and incomplete surgical removal of the tumor. The study will explore the effectiveness of a new treatment approach using a combination of carboplatin and paclitaxel, which are chemotherapy drugs. These drugs are typically used to treat ovarian cancer, but this trial will test a new dosing schedule that involves more frequent, smaller doses, known as a "weekly dose-dense regimen." The goal is to see if this new approach is more effective than the standard treatment, which involves larger doses given every three weeks.

In addition to carboplatin and paclitaxel, the study will also involve the use of bevacizumab, a medication that helps prevent the growth of blood vessels that supply the tumor, and filgrastim, which is used to boost white blood cell counts and help the body fight infections during chemotherapy. Some patients in the study will receive a placebo instead of bevacizumab to compare the effects. The trial aims to determine if the new treatment plan can improve outcomes for patients, such as increasing the chances of successful surgery and extending survival times.

Participants in the study will receive treatment over a period of up to 64 weeks. The study will monitor various outcomes, including the overall response to treatment, progression-free survival (the time during which the cancer does not get worse), and overall survival. The trial will also assess the quality of life of participants and gather information on any side effects experienced. The findings from this study could help improve treatment strategies for patients with ovarian cancer who have a poor prognosis.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, eligibility is confirmed based on specific criteria, including age, diagnosis, and previous treatment history.

    Consent is required to participate in the study, ensuring understanding of the trial's purpose and procedures.

  2. Step 2

    Initial treatment phase

    The initial treatment involves receiving a standard chemotherapy regimen consisting of carboplatin and paclitaxel every three weeks for 3 to 4 cycles.

    This phase assesses the response to the standard treatment and determines eligibility for the next phase based on specific criteria, such as the KELIM score, which measures chemosensitivity.

  3. Step 3

    Randomization and treatment adjustment

    Participants are randomly assigned to either continue the standard chemotherapy regimen or switch to a weekly dose-dense regimen.

    The weekly dose-dense regimen involves more frequent administration of carboplatin and paclitaxel to potentially improve treatment outcomes.

  4. Step 4

    Additional medication

    During the trial, additional medications such as filgrastim may be administered to support blood cell production.

    Bevacizumab may also be included in the treatment plan to inhibit tumor growth by targeting blood vessel formation.

  5. Step 5

    Monitoring and follow-up

    Regular monitoring through scheduled visits and examinations is conducted to assess treatment effectiveness and manage any side effects.

    Follow-up includes evaluating overall response, progression-free survival, and quality of life through questionnaires and medical assessments.

  6. Step 6

    Completion of trial

    The trial is expected to conclude by the end of 2028, with ongoing assessments of survival rates and treatment outcomes.

    Participants may continue to receive follow-up care and monitoring as part of the study's long-term evaluation.

Who can join the trial?

10 criteria

  • Patients must have a confirmed diagnosis of high-grade epithelial ovarian, primary peritoneal, or fallopian-tube cancer. This includes specific types like serous, endometrioid, or carcinosarcoma with at least 30% of the tumor being epithelial.
  • Patients must be adults, aged 18 years or older.
  • The disease must be at an advanced stage, specifically stage III or IV.
  • Patients should have been treated with 3 to 4 cycles of a standard chemotherapy regimen called carboplatin-paclitaxel before joining the study. They should have a poor response to this treatment, shown by an unfavorable **KELIM** score of less than 1.0. This score is a measure of how the cancer responds to chemotherapy. Additionally, the cancer should not be suitable for complete surgical removal.
  • Patients must have an **ECOG performance status** of 0 or 1. This is a scale that measures how well a patient can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
  • Patients need to have adequate organ and bone marrow function to handle the chemotherapy. This includes having enough red blood cells, white blood cells, and platelets.
  • Patients must have proper kidney and liver function. This includes specific levels of liver enzymes, bilirubin, albumin, and creatinine clearance, which are measures of how well the liver and kidneys are working.
  • Patients must provide written consent to participate in the study.
  • Patients must be affiliated with a social insurance regime.
  • Patients must be willing and able to follow the study protocol, which includes attending treatment sessions, scheduled visits, and examinations.

Who cannot join the trial?

7 criteria

  • Patients with **poor prognostic ovarian cancers**. This means the cancer does not respond well to treatment and surgery cannot remove all of it.
  • Patients who have a **poor chemosensitivity**. This means the cancer does not respond well to chemotherapy.
  • Patients with an **unfavorable KELIMTM score** less than 1.0. This score helps predict how well the cancer will respond to treatment.
  • Patients whose disease cannot be completely removed by surgery.
  • Only **female patients** are eligible, so male patients cannot participate.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a **vulnerable population** are not eligible. This refers to groups of people who may need special protection or care.
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Investigated drugs

  • Carboplatin

    is a chemotherapy medication used to treat ovarian cancer. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing. In this trial, carboplatin is used as part of a treatment regimen to evaluate its effectiveness in patients with poor prognostic ovarian cancer.

  • Paclitaxel

    is another chemotherapy drug used in the treatment of ovarian cancer. It helps stop the growth of cancer cells by inhibiting their ability to divide. In the trial, paclitaxel is combined with carboplatin to assess whether a more frequent dosing schedule can improve outcomes for patients with challenging cases of ovarian cancer.

What is already known about the treatment

  • Carboplatin

    This medication is administered intravenously and is commonly used in the treatment of ovarian cancer. It is currently well-established in medical practice and literature as a standard chemotherapy agent. Carboplatin is primarily indicated for patients with ovarian cancer, especially those with poor prognostic factors. It works by interfering with the DNA of cancer cells, preventing them from dividing and growing. Carboplatin is classified as a platinum-based chemotherapy drug.

  • Paclitaxel

    This medication is also administered intravenously and is used alongside carboplatin in the treatment of ovarian cancer. It is a well-known and widely used chemotherapy drug in medical literature. Paclitaxel is indicated for ovarian cancer patients, particularly those with poor prognostic outcomes. It functions by stabilizing the microtubule structures in cells, which inhibits cell division. Paclitaxel is classified as a taxane chemotherapy agent.

Investigated diseases

Ovarian Cancer – Ovarian cancer 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, making it more challenging to treat. The disease is characterized by the growth of abnormal cells that have the ability to invade or spread to other parts of the body. Symptoms can be vague and may include bloating, pelvic pain, and difficulty eating. The progression of ovarian cancer can vary, with some tumors being more aggressive and others growing more slowly. Factors such as tumor chemosensitivity and the success of surgical removal can influence the disease's progression.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508260-30-01Protocol codeGINECO-OV130bEstimated enrolment165 patientsSponsorArcagy Gineco

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).