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Study on Doxorubicin Hydrochloride and Trabectedin for Patients with Recurrent Ovarian Cancer

Fast replyRegistered drugNo placebo
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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 recurrent ovarian cancer, a condition where ovarian cancer returns after treatment. The study is testing a combination of two treatments: pegylated liposomal doxorubicin and trabectedin. Pegylated liposomal doxorubicin is a form of chemotherapy that uses a special coating to help the drug stay in the body longer, while trabectedin is another type of chemotherapy that works by interfering with the cancer cells' ability to grow and divide.

The purpose of the study is to see if this combination of treatments is effective in patients whose ovarian cancer has come back after previous treatment. Participants in the study will receive these medications through an intravenous infusion, which means the drugs are given directly into a vein. The study will take place over several months, with regular visits to monitor the effects of the treatment and to check on the participants' health.

Throughout the study, doctors will assess how well the cancer responds to the treatment and monitor any side effects. The goal is to determine if this combination can help manage the cancer in patients who have already been treated with pegylated liposomal doxorubicin and have experienced a return of their cancer. This research could provide valuable information for future treatment options for recurrent ovarian cancer.

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 such as age, health status, and previous treatments.

    A negative pregnancy test is required for women of child-bearing potential, and effective contraception must be used during treatment and for three months afterward.

  2. Step 2

    Treatment initiation

    The treatment involves the administration of two medications: pegylated liposomal doxorubicin and trabectedin.

    Both medications are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

  3. Step 3

    Medication administration

    Pegylated liposomal doxorubicin is administered as a concentrate for solution for infusion at a dosage of 2 mg/ml.

    Trabectedin is also administered intravenously, but specific dosage and frequency details are determined by the healthcare provider based on individual patient needs.

  4. Step 4

    Monitoring and evaluation

    Throughout the trial, response and progression are evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

    Regular monitoring of health status, including blood tests and imaging, is conducted to assess the effectiveness of the treatment and manage any side effects.

  5. Step 5

    Completion of the trial

    The estimated end date for the trial is May 31, 2025.

    Upon completion, final evaluations are conducted to determine the overall response to the treatment.

Who can join the trial?

15 criteria

  • Must be a female aged 18 years or older.
  • Have liver function tests (AST and ALT) that are no more than 2.5 times the upper limit of normal.
  • Have a normal heart function test (LVEF) using a MUGA scan or 2D-ECHO.
  • If able to have children, must use effective birth control during treatment and for 3 months after, unless postmenopausal or surgically sterilized.
  • Must not be pregnant, confirmed by a negative pregnancy test.
  • Must not be breastfeeding.
  • Must have recovered from any side effects of previous treatments.
  • Must have a confirmed diagnosis of invasive epithelial ovarian cancer, primary peritoneal carcinoma, or fallopian tube cancer.
  • Must be partially or fully sensitive to platinum treatments but unable or unwilling to receive more platinum treatments, and have previously received pegylated liposomal doxorubicin (PLD).
  • Must have an ECOG performance status of 0-1, which means being fully active or having some symptoms but still able to carry out light work.
  • Must have measurable disease as shown by imaging tests, according to specific criteria (RECIST 1.1).
  • Must be able to receive IV dexamethasone or a similar IV steroid medication.
  • Must have the following blood test results: hemoglobin of at least 9 g/dL, albumin greater than 25 g/L, absolute neutrophil count (ANC) over 1,500/μL, platelet count over 100,000/μL, normal kidney function (serum creatinine ≤1.5 mg/dL or a calculated filtration rate >60 mL/min/1.73 m²), and CPK less than 2.5 times the upper limit of normal.
  • Must have total bilirubin no more than 1.5 times the upper limit of normal, with further tests for Gilbert’s syndrome if needed.
  • Must have alkaline phosphatase (ALP) no more than 2.5 times the upper limit of normal, with additional tests if ALP is higher.

Who cannot join the trial?

7 criteria

  • Patients who have not experienced a return of their ovarian cancer.
  • Patients who have not previously been treated with **pegylated liposomal doxorubicin**. This is a type of chemotherapy drug used to treat cancer.
  • Patients who have not had their cancer return within 6-12 months after finishing their last **platinum-based treatment**. Platinum-based treatments are a group of chemotherapy drugs that contain the metal platinum.
  • Patients who are not fully sensitive to platinum treatments. Being "sensitive" means the cancer responds well to the treatment.
  • Patients who are able and willing to receive other platinum treatments.
  • Male patients, as the study is only for female patients.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • Pegylated Liposomal Doxorubicin

    This medication is a form of chemotherapy used to treat ovarian cancer. It is designed to help kill cancer cells and slow down their growth. The drug is enclosed in tiny fat-like particles called liposomes, which help it stay in the body longer and target cancer cells more effectively.

  • Trabectedin (Yondelis®)

    This is another chemotherapy drug used in the treatment of ovarian cancer. Trabectedin works by interfering with the DNA in cancer cells, preventing them from multiplying and spreading. It is often used in combination with other cancer treatments to improve effectiveness.

What is already known about the treatment

  • Pegylated Liposomal Doxorubicin

    This medication is administered intravenously and is used in the treatment of recurrent ovarian cancer. It is currently recognized in medical literature as an effective option for patients who have previously been treated with doxorubicin. The main therapeutic indication is for relapsed ovarian cancer, particularly in patients who have progressed within 6-12 months after their last platinum-based treatment. At the molecular level, it works by intercalating DNA, disrupting the replication process, and ultimately leading to cancer cell death. It is classified as an anthracycline antibiotic.

  • Trabectedin (Yondelis®)

    This medication is also administered intravenously and is used in combination with pegylated liposomal doxorubicin for treating recurrent ovarian cancer. It is well-documented in medical literature as a treatment for soft tissue sarcoma and ovarian cancer. The main therapeutic indication is for patients with relapsed ovarian cancer who are not suitable for further platinum-based therapies. Trabectedin works by binding to the minor groove of DNA, interfering with cell division and leading to cancer cell death. It is classified as an alkylating agent.

Investigated diseases

Recurrent Ovarian Cancer – This is a condition where ovarian cancer returns after a period of remission. It typically occurs when cancer cells that were not completely eliminated during initial treatment begin to grow again. The progression of recurrent ovarian cancer can vary, with some cases showing slow growth while others may progress more rapidly. Symptoms may include abdominal pain, bloating, and changes in bowel habits. The disease can spread to other parts of the body, affecting organs such as the liver and lungs. Management often focuses on controlling symptoms and slowing the progression of the disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518847-40-00Protocol codeREPRAB - MITO 36Estimated enrolment64 patientsSponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

sourced from the EU Clinical Trials Register and site verification

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