RecruitingRare disease

Study on the Effectiveness of Adding Progesterone to Chemotherapy with Etoposide, Doxorubicin, Cisplatin, and Mitotane for Advanced Adrenocortical Carcinoma Patients

Verified siteRegistered drug

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 rare type of cancer called adrenocortical carcinoma, which affects the outer layer of the adrenal glands. The study aims to evaluate the effectiveness of adding a hormone called progesterone to a standard chemotherapy treatment. The chemotherapy regimen includes medications such as cisplatin, etoposide, and doxorubicin, which are administered through an intravenous infusion, meaning they are given directly into a vein. Additionally, a medication called mitotane is included, which is taken orally in tablet form. Some participants will receive a placebo instead of progesterone to compare the outcomes.

The purpose of this study is to assess how well the combination of these treatments works in patients with advanced or metastatic adrenocortical carcinoma, meaning the cancer has spread to other parts of the body. Participants will be randomly assigned to receive either the combination of chemotherapy with progesterone or chemotherapy with a placebo. The study will monitor the participants over a period to see how the cancer responds to the treatment.

Throughout the study, participants will receive regular medical check-ups and monitoring to ensure their safety and to track the progress of the treatment. The study is designed to provide valuable information on whether adding progesterone to the standard chemotherapy regimen can improve outcomes for patients with this challenging form of cancer.

The research process

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

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of adrenocortical carcinoma (ACC) and ensuring the disease is advanced or metastatic.
Eligibility criteria include being over 18 years old, having a life expectancy of more than 3 months, and adequate bone marrow and organ function.
Step 2
Treatment allocation
Participants are randomly assigned to one of two treatment groups. One group receives the combination of EDP-M plus progesterone, while the other group receives EDP-M plus a placebo.
EDP-M refers to a combination of etoposide, doxorubicin, cisplatin, and mitotane.
Step 3
Medication administration
Cisplatin is administered through an intravenous (IV) infusion.
Etoposide is also given via IV infusion.
Doxorubicin is administered through IV infusion as well.
Mitotane is taken orally in tablet form.
Progesterone or placebo is administered according to the assigned group.
Step 4
Treatment cycle
The treatment is given in cycles, with specific dosages and schedules determined by the study protocol.
Regular monitoring and assessments are conducted to evaluate the response to treatment and manage any side effects.
Step 5
Follow-up assessments
Throughout the trial, follow-up assessments are performed to measure the effectiveness of the treatment.
The primary goal is to compare the proportion of patients achieving an objective response between the two treatment groups.
Step 6
Completion of trial
The trial is expected to conclude by December 31, 2026.
Final assessments will be conducted to gather data on the long-term effects and outcomes of the treatment.

Who can join the trial?

8 criteria

Have a confirmed diagnosis of **adrenocortical carcinoma (ACC)**, which is a type of cancer that starts in the adrenal glands.
Have cancer that is either **locally advanced** (spread to nearby areas) or **metastatic** (spread to other parts of the body) and cannot be removed with surgery.
Have an **ECOG performance status** of 0-2, which means you are fully active or have some limitations but can still take care of yourself.
Use **effective contraception** to prevent pregnancy during the study.
Have a **life expectancy** of more than 3 months.
Be older than 18 years.
Have enough healthy blood cells and proper function of organs like the kidneys, liver, and heart. This means having **neutrophils** (a type of white blood cell) greater than 1,000 per mm³ and **platelets** (cells that help with blood clotting) greater than 80,000 per mm³.
Be able to follow the study procedures and provide **written informed consent**, which means you understand the study and agree to participate.

Who cannot join the trial?

10 criteria

Patients who have a different type of cancer other than adrenocortical carcinoma (a rare cancer that starts in the outer layer of the adrenal glands).
Patients who are not in the advanced or metastatic stage of the disease. Metastatic means the cancer has spread to other parts of the body.
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study procedures or take the study medications as required.
Patients who are pregnant or breastfeeding.
Patients who have another serious medical condition that might interfere with the study.
Patients who are participating in another clinical trial at the same time.
Patients who have had a recent surgery or treatment that might affect the study results.
Patients who have a known allergy to any of the study medications.
Patients who have a history of drug or alcohol abuse.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Universita Degli Studi Di Brescia
Verified
Brescia, Italy

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Progesterone
is a hormone that is being tested in this trial to see if it can improve the effectiveness of the standard chemotherapy treatment for patients with advanced adrenal cortical carcinoma. It is being added to the usual treatment to see if it helps in controlling the cancer better.
Mitotane
is a medication used to treat adrenal cortical carcinoma. It works by reducing the production of hormones from the adrenal gland and is part of the standard treatment regimen in this trial.
EDP Scheme
refers to a combination of chemotherapy drugs used to treat adrenal cortical carcinoma. This scheme typically includes drugs that work together to stop the growth of cancer cells. The exact drugs in the EDP scheme are not specified here, but they are part of the standard treatment for this type of cancer.

What is already known about the treatment

Progesterone – Progesterone is administered orally or via injection, depending on the specific treatment protocol. It is currently being studied in clinical trials for its potential benefits when added to standard chemotherapy for advanced adrenal cortical carcinoma. The main therapeutic indication in this context is to enhance the efficacy of existing chemotherapy regimens. At the molecular level, progesterone works by binding to progesterone receptors, influencing gene expression and cellular responses. It is classified as a hormone therapy, specifically a progestin, which is a synthetic form of the naturally occurring hormone progesterone.

Investigated diseases

Adrenocortical carcinoma – This is a rare type of cancer that originates in the outer layer of the adrenal glands, which are located on top of the kidneys. The disease can cause the adrenal glands to produce excess hormones, leading to symptoms such as high blood pressure, weight gain, and changes in mood or behavior. As the cancer progresses, it may spread to other parts of the body, including the liver, lungs, and bones. The growth of the tumor can lead to abdominal pain or a feeling of fullness. Adrenocortical carcinoma is often aggressive, and its progression can vary significantly among individuals.