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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Ospedale Vito Fazzi Lecce	Lecce	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Istituto Tumori Bari Giovanni Paolo II	Bari	Italy
Azienda Ospedaliera Ordine Mauriziano Di Torino	Turin	Italy
Azienda Unita’ Locale Socio Sanitaria N. 2 Marca Trevigiana	Treviso	Italy
Azienda USL Toscana Centro	Prato	Italy
Ijkpqt Iymcvxso Fgauimkyjwsva Onwungcbdew	Rome	Italy
Iychfmwz Rbeemxjyy Pxv Lk Sgneew Dqe Tsqlqm Dswy Atpjfku Irur Slloil	Meldola	Italy
Ujhxorsavj Dmfns Skmyx Dj Rwgj Lv Sbperqgn	Rome	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	01.10.2020

Trial locations

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.

Investigated diseases:

Ovarian cancer

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 ID:

2024-518847-40-00

Protocol code:

REPRAB – MITO 36

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?