Study of Lurbinectedin and Doxorubicin for First-line Treatment in Patients with Metastatic Leiomyosarcoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called metastatic leiomyosarcoma, which is a cancer that starts in smooth muscle tissue and has spread to other parts of the body. The study is testing a new treatment combination to see if it can help patients with this condition. The treatment being studied includes a drug called lurbinectedin, which is being tested in combination with another drug called doxorubicin hydrochloride. Doxorubicin hydrochloride is already used in cancer treatment, and this study aims to find out if adding lurbinectedin can improve outcomes for patients.

The purpose of the study is to determine if the combination of lurbinectedin and doxorubicin hydrochloride can help patients live longer without their cancer getting worse, compared to using doxorubicin hydrochloride alone. Patients participating in the study will receive these medications through an intravenous (IV) infusion, which means the drugs are given directly into a vein. The study will compare the effects of the combination treatment to the effects of doxorubicin hydrochloride alone, to see which is more effective as a first-line treatment for metastatic leiomyosarcoma.

Participants in the study will be randomly assigned to receive either the combination of lurbinectedin and doxorubicin hydrochloride or doxorubicin hydrochloride alone. The study will be conducted over a period of time, and patients will be monitored to see how their cancer responds to the treatment. The study will also look at the safety of the treatments and any side effects that may occur. This research is important to help find better ways to treat metastatic leiomyosarcoma and improve the quality of life for patients with this condition.

1 joining the study

Upon joining the study, the patient will be randomly assigned to one of two groups: one receiving a combination of lurbinectedin and doxorubicin, and the other receiving doxorubicin alone.

The study is designed to evaluate the effectiveness of these treatments in patients with metastatic leiomyosarcoma, a type of cancer that has spread to other parts of the body.

2 treatment administration

The patient will receive the assigned treatment intravenously. This means the medication will be delivered directly into the bloodstream through a vein.

For those in the combination group, lurbinectedin and doxorubicin will be administered together. The specific dosage and frequency will be determined by the study protocol.

3 monitoring and assessments

Throughout the study, the patient’s health and response to treatment will be closely monitored. This includes regular medical assessments and imaging tests to measure the size and spread of the cancer.

The patient’s quality of life will also be evaluated using a questionnaire designed to capture their experiences and any side effects they may encounter.

4 follow-up and conclusion

The study will continue until the estimated end date in April 2029, or until the patient completes their treatment course.

After the treatment phase, follow-up visits will be scheduled to monitor the patient’s long-term health and any potential late effects of the treatment.

Who Can Join the Study?

The patient must voluntarily sign and date a written informed consent form before any study-specific procedures begin.
The patient must be at least 18 years old.
The patient must have a confirmed diagnosis of metastatic leiomyosarcoma (LMS), which means the cancer has spread to other parts of the body, and they are not candidates for surgery that could cure the disease.
The patient must have a disease that can be measured using imaging techniques, according to a specific set of guidelines called RECIST v.1.1.
The patient must not have received any previous systemic therapy for metastatic disease, meaning this is their first treatment for cancer that has spread. They also must not have received a type of drug called anthracyclines before. However, previous chemotherapy without anthracyclines is allowed if it was given as part of treatment before or after surgery.
The patient must have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but can still carry out light work.
The patient must have adequate blood, kidney, liver, and heart function, as shown by specific medical tests:

Hemoglobin level of at least 9.0 g/dL. Patients may have received a blood transfusion before.
Absolute neutrophil count (ANC) of at least 2.0 x 10⁹/L, and platelet count of at least 100 x 10⁹/L.
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels no more than 3 times the upper limit of normal.
Total bilirubin level within normal limits, or direct bilirubin within normal limits if total bilirubin is higher.
Albumin level of at least 3.0 g/dL.
Creatinine clearance of at least 30 mL/min, which is a measure of kidney function.
Left ventricular ejection fraction (LVEF) greater than 50%, which is a measure of heart function, assessed by specific heart imaging tests.

The patient must have waited a certain amount of time since their last treatment or surgery:

At least three weeks since the last systemic treatment.
At least three weeks since major surgery and one week since minor surgery.
At least two weeks since the last radiotherapy session.

Women who can have children must show evidence that they are not currently able to become pregnant. They must agree to use a highly effective form of birth control during the study and for seven months after stopping treatment. Men with partners who can have children should use condoms during treatment and for four months after the last dose of the study drug.

Who Cannot Join the Study?

Patients who have a different type of cancer other than metastatic leiomyosarcoma. Metastatic means the cancer has spread to other parts of the body.
Patients who have already received treatment for their metastatic leiomyosarcoma. This study is for those who have not yet been treated.
Patients who are not within the specified age range for the study. The study has specific age requirements.
Patients who are not able to follow the study procedures or attend the required visits.
Patients who have other serious health conditions that might interfere with the study treatment.
Patients who are pregnant or breastfeeding, as the study treatment might affect the baby.
Patients who are participating in another clinical trial at the same time.
Patients who have allergies or reactions to the study medications or similar drugs.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
IRCCS Humanitas Research Hospital	Rozzano	Italy
Medical University Of Vienna	Vienna	Austria
Medical University Of Graz	Graz	Austria
Medizinische Universitaet Innsbruck	Innsbruck	Austria
Institut Gustave Roussy	Villejuif	France
Technische Universitaet Dresden	Dresden	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium
Medizinische Hochschule Hannover	Hanover	Germany
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Institut Curie – Site Paris	Paris	France
Comite Entreprise Paul Papin	Angers	France

Other Sites

Site Name	City	Country
Centre Antoine Lacassagne	Nice	France
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.	Porto	Portugal
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.	Lisbon	Portugal
Hospital Universitario De Canarias	La Laguna	Spain
Centro Di Riferimento Oncologico Di Aviano	Aviano	Italy
Cixhuhjbx Uklhzheojrgeys Sxmlyskoi	Woluwe-Saint-Lambert	Belgium
Ikwtlgzm Jozas Broufd	Anderlecht	Belgium
Hgggwpuq Vhym drnexibw	Barcelona	Spain
Hasrrcgh Ujfydvubrsriy dq A Ceivvt	A Coruna Galicia	Spain
Vaidxl ddm Raqhj Uctusoxvsi Hqxscdjw	Sevilla	Spain
Uehknhsogkxovjbcxxoyu Tyeswcufy Aph	Tuebingen	Germany
Aluptiumop Postlopv Hddsasfw Dp Mtbmzqxcw	Marseille	France
Hiqrbusg Utsoasvjiqqui Foezsaxme Jeinhwc Dykz	Madrid	Spain
Ujanejrmrmea Dp Scytvuqq Dr Cejidawwqk	Santiago De Compostela	Spain
Cqwnyq Hhxthtswol E Uhatyjfgqsjga Db Cgxmrpu Eyskwn	Coimbra	Portugal
Hsvkhnki Cpltcom Snr Cpmxsn	Madrid	Spain
Amyqnby Oywqrrosonb Uqzvupcqipwer Cujyiiznprxm Dbzor Sntkba E Dfqik Sgjwkym Dk Tyjzym	Turin	Italy
Ujnwonmptneoslxmfavmo Mxrfheic Akd	Munster	Germany
Uztwyfmjryninxugnozij Hpitlzumqe Agi	Heidelberg	Germany
Kesajpjn dwu Ubgpimuxbfys Mcvehfkk Asl	Munich	Germany
Alwoxmx Umphy Stfroeamh Lxkgie Dd Bkjtpoo	Bologna	Italy
Cwmvmr Hckkbwhbeg Umjjxighhyfel Dp Srmqf Avpcifn Efbqpx	Porto	Portugal
Holtljxw Dp Lx Sjkrb Ckim I Sruh Ppc	Barcelona	Spain
Csnopx Lnnd Brvmtd	Lyon	France
Iwixba Ikvqjqsb Fcpocmjdycxug Ogrmwnoljkm	Rome	Italy
Odtrvietgppqkh Lqbd Gbbu	Linz	Austria
Idcvicdn foha Kdxjcxzrg Tzyoihpzgjfcagtjxiq uwj Iiohnbutrriw Uxd gvcyx	Ulm	Germany
Vaant Ueplyfytkzcw Buxqwqc	Jette	Belgium
Isxddsmw Cpmrsv Ditqhkbgqkjqwgory	L'hospitalet De Llobregat	Spain
Srujrnme Pdsnduwhh Sik z oilx	Gdynia	Poland
Ihidevys Ojwessodry Vwrnzm	Padua	Italy
Cmxgwb Dh Lhyrp Chusnz Lo Ctezel Emvwtu Memrpks	Rennes	France
Cbfnaq Huoitwsygvx Ek Urbbrebpcipzm Df Lbyavhm	Limoges	France
Ajmymrk Oyngnffakjkgbdpalshwhiauk Ssp Lztbk Gcrxzbt	Orbassano	Italy
Uwcfqtkanhjmqypkj Cyxpqd Bkzpumetoo Dr Rbqs	Rome	Italy
Ibcjqdxs Do Cxcngqwq Frqljjpgsy Dzn Pwoqltyh Pvf Layjiegtim Ialzu	Candiolo	Italy
Beopzjxh Ubcqwuhtvr Htwitsxz Cjiwni	Besançon	France
Nmdknwfz Iowcwrul Ojqlujzvc Irb Mvemx Selwpwoorslyohcoxqvixjbcyver Isxtgqhk Bpezgver	Cracow	Poland
Nwfgrjrwtsq Cfkytl Iclttmvez	Amsterdam	The Netherlands
Iwxmdztv Opxefhdptw Rpxehuk	Bologna	Italy
Ccrfdx Hhzksfscdig Uewhkhgtwnncw Dh Pwsuoliv	Poitiers	France
Lnnli Utdnjhyivtfz Mszzgnv Crfkaqi (ttsmp	Leiden	The Netherlands
Hxwthk Klraskqi Bmg Swvvex Gaud	Bad Saarow	Germany
Alwwtbc Oacmgdtyjfg Udggftriglzxj Pncuuevcdji Pkxhj Gqgysuhs	Palermo	Italy

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	15.12.2023
Belgium	Not recruiting	15.12.2023
France	Not recruiting	15.12.2023
Germany	Not recruiting	15.12.2023
Italy	Not recruiting	15.12.2023
Poland	Not recruiting	15.12.2023
Portugal	Not recruiting	15.12.2023
Spain	Not recruiting	15.12.2023
The Netherlands	Not recruiting	15.12.2023

Trial locations

Investigated Drugs:

Lurbinectedin is a medication being studied for its potential to treat metastatic leiomyosarcoma, a type of cancer. In this trial, it is used in combination with another drug to see if it can help slow down the progression of the disease.

Doxorubicin is a chemotherapy drug that is commonly used to treat various types of cancer, including leiomyosarcoma. In this study, it is used both alone and in combination with lurbinectedin to determine its effectiveness in treating metastatic leiomyosarcoma.

Metastatic Leiomyosarcoma – Metastatic leiomyosarcoma is a rare type of cancer that originates in smooth muscle tissue and has spread to other parts of the body. It often begins in the uterus, stomach, or intestines, but can also arise in other areas where smooth muscle is present. As the disease progresses, cancer cells travel through the bloodstream or lymphatic system to form new tumors in distant organs. This spread can lead to complications depending on the organs affected. The disease is characterized by the uncontrolled growth of abnormal cells, which can disrupt normal bodily functions. Symptoms may vary based on the location and size of the tumors.

Trial ID:

2022-502975-45-00

Protocol code:

PM1183-C-010-22

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Lurbinectedin and Doxorubicin for First-line Treatment in Patients with Metastatic Leiomyosarcoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?