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Study Comparing Trabectedin and Gemcitabine for Patients with Advanced or Metastatic Leiomyosarcoma After Chemotherapy

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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 a type of cancer called leiomyosarcoma, which can either spread to other parts of the body (metastatic) or grow in a specific area (locally advanced). The study is comparing two treatments: Trabectedin and Gemcitabine. Both medications are given as a solution through a vein, known as an infusion. The purpose of the study is to compare how well these treatments work in patients who have already received chemotherapy based on a drug called anthracycline.

Participants in the study will receive either Trabectedin or Gemcitabine. The study will observe how the cancer responds to these treatments over time. The main focus is on the growth modulation index (GMI), which is a way to measure how the cancer's growth is affected by the treatment. A GMI greater than 1.33 is considered a positive sign in this type of study. The study will also look at other factors, such as how long patients live, how long they live without the cancer getting worse, and how safe and tolerable the treatments are.

The study will continue for a period of time, during which patients will be monitored regularly to assess the effectiveness and safety of the treatments. The goal is to gather information that could help improve treatment options for patients with advanced leiomyosarcoma. This study is part of ongoing research to find better ways to manage and treat this type of 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.

Step 1
Joining the study
Upon joining the study, the patient will be randomly assigned to receive either trabectedin or gemcitabine as a treatment for metastatic or locally advanced leiomyosarcoma.
The patient must have completed any previous cancer treatments at least 21 days before starting the study medication.
Step 2
Treatment administration
The patient will receive the assigned medication through an intravenous infusion. This means the medication will be delivered directly into the bloodstream through a vein.
For gemcitabine, the concentration is 100 mg/ml. The specific dosage and frequency will be determined by the healthcare provider based on individual patient needs.
For trabectedin, the available dosages are 0.25 mg and 1 mg. The healthcare provider will determine the appropriate dosage and frequency.
Step 3
Monitoring and assessments
Throughout the trial, the patient's response to the treatment will be monitored using imaging tests and other assessments to evaluate the size and progression of the tumor.
The patient's overall health, including blood counts and organ function, will be regularly checked to ensure safety and adjust treatment as necessary.
Step 4
Evaluation of treatment effectiveness
The effectiveness of the treatment will be measured by comparing the time it takes for the disease to progress with the current treatment to the time it took with previous treatments.
A key measure is the growth modulation index (GMI), which helps determine the activity of the treatment. A GMI greater than 1.33 is considered a positive sign.
Step 5
Completion of the trial
The trial is expected to continue until January 18, 2026, or until the patient completes the treatment protocol.
Upon completion, the patient's overall response to the treatment, including survival rates and any side effects experienced, will be evaluated.

Who can join the trial?

26 criteria

Patients must have a confirmed diagnosis of **leiomyosarcoma**, which is a type of cancer that affects smooth muscle tissue.
All previous cancer treatments must have been completed at least 3 weeks (21 days) before starting the study drug.
Any side effects from previous treatments, except hair loss, must be reduced to a mild level, as defined by specific medical guidelines.
Patients must have adequate bone marrow, liver, and kidney function, as shown by specific blood tests:
Hemoglobin level of at least 9 g/dl.
White blood cell count (neutrophils) of at least 1,500 per mm³.
Platelet count of at least 100,000 per mm³.
Total bilirubin within normal limits.
Liver enzymes (AST/ALT) no more than 2.5 times the normal limit.
Alkaline phosphatase no more than 2.5 times the normal limit.
Blood clotting tests (PT-INR/PTT) less than 1.5 times the normal limit.
Serum creatinine within 1.5 times the normal limit or a creatinine clearance of at least 30 mL/min.
Albumin level of at least 25 g/l.
Creatine phosphokinase (CPK) no more than 2.5 times the normal limit.
The heart's pumping ability (Left Ventricular Ejection Fraction) must be at least 50%.
Women who can have children must have a negative pregnancy test before each chemotherapy cycle. Both men and women must agree to use effective birth control during the study and for a period after the study ends.
No history of blood clots in the arteries or veins in the past 12 months.
Patients or their legal representatives must be able to read and understand the consent form and agree to participate in the study.
Patients must have **unresectable** (cannot be removed by surgery) or **metastatic** (spread to other parts of the body) leiomyosarcoma.
Patients must have received previous treatment with **Anthracycline-based chemotherapy** for advanced disease.
Patients must be suitable to receive **gemcitabine** or **Trabectedin** therapy.
Patients must have measurable or evaluable disease according to specific criteria (RECIST 1.1).
There must be evidence of disease progression within 6 months before entering the study, according to RECIST 1.1 criteria.
Availability of specific dates related to previous treatments and assessments is required.
Patients must be at least 18 years old.
Patients must have an **ECOG Performance Status** of 2 or less, which is a measure of their ability to perform daily activities.

Who cannot join the trial?

4 criteria

Patients who have not been previously treated with **anthracycline-based chemotherapy**. This is a type of cancer treatment that uses drugs to kill cancer cells.
Patients who have a different type of cancer other than **leiomyosarcoma**, which is a rare type of cancer that affects smooth muscle tissue.
Patients who are part of a **vulnerable population**, meaning they might have special needs or circumstances that require extra protection.
Patients who are not within the specified age range for the study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Verified
Palermo, Italy
Istituto Europeo Di Oncologia S.r.l.
Responsive
Milan, Italy
Istituto Oncologico Veneto
Responsive
Padua, Italy

Trial locations

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Investigated drugs

Trabectedin
is a medication used in this trial to treat patients with metastatic or locally advanced leiomyosarcoma. It is being tested to see how well it can slow down or stop the growth of cancer cells in patients who have already received other chemotherapy treatments. Trabectedin works by interfering with the DNA in cancer cells, which may help to prevent them from growing and spreading.
Gemcitabine
is another medication being tested in this trial for the same type of cancer. It is used to see if it can effectively control the disease in patients who have previously been treated with chemotherapy. Gemcitabine works by blocking the ability of cancer cells to make DNA, which is necessary for them to grow and divide. This may help to slow down or stop the progression of the cancer.

What is already known about the treatment

Trabectedin
Trabectedin is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating metastatic or locally advanced leiomyosarcoma, particularly in patients who have already undergone conventional chemotherapy. It is primarily used for its potential to slow the progression of this type of cancer. At the molecular level, Trabectedin works by binding to the DNA in cancer cells, disrupting their ability to divide and grow. It is classified as an antineoplastic agent, which means it is used to prevent the growth and spread of tumors.
Gemcitabine
Gemcitabine is given through an intravenous infusion and is being evaluated in clinical trials for its role in managing metastatic or locally advanced leiomyosarcoma in patients previously treated with standard chemotherapy. It is indicated for its potential to inhibit cancer cell growth. The drug acts by incorporating itself into the DNA of cancer cells, leading to cell death. Gemcitabine is classified as an antimetabolite, a type of chemotherapy that interferes with the DNA synthesis of cancer cells.

Investigated diseases

Leiomyosarcoma – Leiomyosarcoma is a type of cancer that originates in smooth muscle tissue, which is found in various parts of the body such as the uterus, stomach, and blood vessels. It is considered a rare form of cancer and can be either localized or metastatic, meaning it can spread to other parts of the body. The disease often begins as a painless lump or swelling and may grow slowly or rapidly, depending on the individual case. As it progresses, it can cause symptoms related to the area of the body it affects, such as abdominal pain or swelling if it occurs in the abdomen. The progression of leiomyosarcoma can vary significantly between patients, with some experiencing slow growth and others facing more aggressive disease.