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Study on Durvalumab with Carboplatin or Cisplatin and Etoposide for First-Line Treatment in Patients with Extensive Stage Extrapulmonary Small Cell Carcinoma

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What is this study about?

This clinical trial is focused on studying a type of cancer known as extensive stage extrapulmonary small cell carcinoma (EPSCC). This is a form of cancer that starts outside the lungs and spreads quickly. The study is testing a treatment that combines several medications to see how effective they are in treating this cancer. The medications being used in this study include Durvalumab, which is a type of drug called a monoclonal antibody that helps the immune system fight cancer, and chemotherapy drugs such as Carboplatin, Cisplatin, and Etoposide. These chemotherapy drugs work by stopping the growth of cancer cells.

The purpose of the study is to evaluate how well this combination of medications works in preventing the cancer from getting worse over a period of 12 months. Patients participating in the study will receive these medications through an infusion, which means the drugs are given directly into the bloodstream through a vein. The study will last for a maximum of 24 months, during which the patients will be monitored regularly to assess the treatment’s effects and any side effects that may occur.

Throughout the study, the health and progress of the patients will be closely observed to determine the safety and effectiveness of the treatment. The study aims to provide valuable information on whether this combination of medications can help improve the quality of life and survival rates for patients with this aggressive form of cancer. Participants will receive regular check-ups and assessments to ensure their well-being and to gather data on the treatment’s impact.

1 initiation of treatment

Upon joining the study, treatment begins with the administration of medications through an infusion. This involves receiving drugs directly into the bloodstream via a vein.

The medications used in this study include cisplatin, carboplatin, durvalumab, and etoposide. These are given as a solution for infusion.

2 medication administration

Cisplatin or carboplatin is administered as part of the treatment regimen. The choice between these two drugs depends on individual patient factors.

Durvalumab is also administered. This medication is part of the treatment plan to help manage the condition.

Etoposide is included in the treatment and is given alongside the other medications.

3 treatment schedule

The treatment is structured in cycles. Each cycle involves receiving the medications over a specific period, followed by a rest period to allow the body to recover.

The exact schedule, including the frequency and duration of each medication, will be provided by the healthcare team based on the study protocol.

4 monitoring and assessments

Throughout the study, regular monitoring and assessments are conducted to evaluate the response to treatment and manage any side effects.

These assessments may include physical exams, blood tests, and imaging studies such as CT or MRI scans.

5 end of treatment

The treatment continues until the study’s end date or until it is determined that the treatment is no longer beneficial.

The study aims to evaluate the effectiveness of the treatment over a 12-month period, focusing on progression-free survival, which means the time during which the disease does not worsen.

Who Can Join the Study?

  • Must be at least 18 years old on the day of signing the consent form.
  • Must have proper organ and bone marrow function, with specific blood test results within normal limits:
    • Hemoglobin level of at least 9.0 grams per deciliter (g/dL).
    • Absolute neutrophil count (ANC) of at least 1.0 x 109 per liter (L).
    • Platelet count of at least 75 x 109 per liter (L).
    • Serum bilirubin level no more than 1.5 times the normal upper limit.
    • AST (SGOT) and ALT (SGPT) levels no more than 2.5 times the normal upper limit, unless there are liver metastases, in which case no more than 5 times the normal upper limit.
  • Must have a creatinine clearance (a measure of kidney function) greater than 40 milliliters per minute (mL/min).
  • Must have a sample of tumor tissue available from a previous biopsy.
  • For women who can have children, must show evidence of being post-menopausal or have a negative pregnancy test.
  • Must have at least one tumor that can be measured accurately, with specific size requirements, using a CT or MRI scan.
  • Must weigh more than 30 kilograms (kg).
  • Must provide written informed consent and any necessary local permissions before any study-related procedures.
  • Must have a confirmed diagnosis of extensive disease extrapulmonary small cell carcinoma.
  • If there are brain metastases, they must not cause symptoms or must be treated and stable without steroids or anti-seizure medication for at least one month before starting the study.
  • Must not have had previous treatment with immune-based therapies, except for certain cancer vaccines.
  • Must not have had previous chemotherapy for advanced disease.
  • Must have a performance status of 0 or 1 on the ECOG Performance Scale, which measures daily living abilities.
  • Must have a life expectancy of at least 12 weeks at the time of joining the study.
  • Must be suitable to receive a chemotherapy treatment that includes platinum-based drugs as the first treatment for extensive stage extrapulmonary small cell carcinoma.

Who Cannot Join the Study?

  • Patients with other types of cancer that are not the focus of this study.
  • Patients who have received certain treatments for cancer before, which might interfere with the study.
  • Patients with serious health conditions that could make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding, as the study treatments might affect the baby.
  • Patients who are unable to follow the study procedures or attend the required visits.
  • Patients with allergies to the study medications or their ingredients.
  • Patients who are participating in another clinical trial at the same time.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli Naples Italy

Other Sites

Site Name City Country Status
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Casa Sollievo Della Sofferenza San Giovanni Rotondo Italy
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Azienda Socio Sanitaria Territoriale Dei Sette Laghi Varese Italy
Azienda Sanitaria Locale Di Taranto Taranto Italy
Universita’ Di Pisa Pisa Italy
Universita’ Politecnica Delle Marche Ancona Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Ixzlbeuf Rslmxtpdl Pwy Lj Sanukc Dzu Tkyhgr Dkhh Alpfacc Izdp Sdzyvy Meldola Italy
Alnjpqc Uyn Iustw Dp Repphm Exfuhr Reggio Emilia Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Recruiting
01.12.2023

Trial locations

Investigated drugs:

Durvalumab is a medication used in this trial to help the immune system fight cancer. It works by blocking a specific protein that can stop the immune system from attacking cancer cells, allowing the body to better target and destroy these cells.

Carboplatin is a chemotherapy drug used to treat various types of cancer. It works by damaging the DNA of cancer cells, which prevents them from dividing and growing, ultimately leading to their death.

Cisplatin is another chemotherapy medication that is used to treat cancer. Similar to carboplatin, it works by causing damage to the DNA of cancer cells, stopping them from multiplying and leading to their destruction.

Etoposide is a chemotherapy drug that helps treat cancer by interfering with the DNA replication process in cancer cells. This interference prevents the cells from dividing and growing, which helps to reduce the size of tumors and slow the progression of the disease.

Investigated diseases:

Extensive Stage Extrapulmonary Small Cell Carcinoma – This is a type of cancer that originates in small cells found in various parts of the body outside the lungs. It is characterized by rapid growth and the potential to spread quickly to other areas. The disease often begins in tissues such as the digestive tract, bladder, or prostate. As it progresses, it can invade nearby organs and spread to distant sites, including the liver, bones, and brain. Symptoms may vary depending on the location of the primary tumor and the extent of spread. The disease is known for its aggressive nature and requires prompt medical attention.

Trial ID:
2023-505078-13-00
Protocol code:
GOIRC‐01‐2021
Trial Phase:
Therapeutic exploratory (Phase II)

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