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Study on Ramucirumab and Paclitaxel for Older Patients with Advanced Stomach Cancer

Verified siteRegistered drugNo placebo

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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 treatments for advanced gastric cancer, which is a type of stomach cancer that has spread to other parts of the body. The study is investigating the effectiveness of two medications: ramucirumab, also known by its code name LY3009806, and paclitaxel. These medications are given as solutions through an intravenous infusion, which means they are administered directly into the bloodstream through a vein.

The purpose of the study is to evaluate the survival and quality of life of patients who receive these treatments. Participants in the study will receive either ramucirumab alone or in combination with paclitaxel. The study will monitor patients over a period to assess how well they respond to the treatment and how it affects their overall well-being. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatments.

The trial is designed for older patients, specifically those aged 70 and above, who have been diagnosed with advanced gastric cancer. The study will track various outcomes, including survival rates and any changes in the patients' quality of life over time. This research aims to provide valuable insights into the potential benefits and side effects of these treatments for older adults with this type 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
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, medical history, and current health status.
Informed consent is required, ensuring understanding of the study's purpose and procedures.
Step 2
Randomization
Participants are randomly assigned to receive either ramucirumab alone or in combination with paclitaxel.
This process ensures unbiased distribution of treatments among participants.
Step 3
Treatment administration
Ramucirumab is administered as a solution for infusion through intravenous use.
Paclitaxel, if applicable, is also administered as a solution for infusion through intravenous use.
The dosage and frequency of administration are determined by the study protocol and medical team.
Step 4
Monitoring and assessments
Regular monitoring of health status and response to treatment is conducted.
Assessments include quality of life evaluations and geriatric parameters every two months.
Toxicities and side effects are observed and graded according to established criteria.
Step 5
Evaluation of outcomes
Primary outcomes include six-month survival rate and quality of life at four months.
Secondary outcomes involve time to treatment failure, progression-free survival, and overall survival.
Data is collected and analyzed to determine the effectiveness and safety of the treatments.
Step 6
Completion of the study
The study is estimated to conclude by July 31, 2025.
Final results are compiled and shared with relevant stakeholders to contribute to medical knowledge and potential future treatments.

Who can join the trial?

9 criteria

The patient must have **stomach cancer stage IV** with **metastases**. This means the cancer has spread to other parts of the body.
The cancer must be **unresectable**, meaning it cannot be removed with surgery, and it must be **metastatic** or **locally advanced**. This refers to cancer that has spread or grown significantly.
The patient must be **70 years or older**.
The patient should have an **estimated life expectancy** of more than **3 months**.
The patient must have a disease that can be measured or not measured according to specific guidelines called **RECIST 1.1 criteria**.
The patient must have shown **progression** of the disease after first-line chemotherapy or within a certain time frame after the last treatment. This means the cancer has continued to grow or spread despite treatment.
The patient must have **adequate haematological, renal, and hepatic function**. This means the blood, kidneys, and liver are working well enough.
The patient must complete specific questionnaires: **QLQ-C30**, **QLQ-ELD-14**, and **Questionnaire gériatrique IADL**. These are tools to assess quality of life and daily living activities.
The patient must provide **signed informed consent**, which means they agree to participate in the study after understanding all the details.

Who cannot join the trial?

3 criteria

Patients who have a different type of cancer than stomach cancer stage IV with metastases cannot participate. Metastases means that the cancer has spread to other parts of the body.
Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who are part of a vulnerable population, which means they might need special protection or care, are not included in this study.

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Verified
Centre Hospitalier Universitaire De Rennes
Rennes, France

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Investigated drugs

Ramucirumab
is a medication used in this clinical trial to treat advanced gastric cancer. It works by blocking a specific protein that helps cancer cells grow new blood vessels, which are necessary for tumors to grow and spread. By inhibiting this protein, ramucirumab aims to slow down or stop the growth of cancer.
Paclitaxel
is another medication used in combination with ramucirumab in this trial. It is a type of chemotherapy that works by stopping cancer cells from dividing and growing. Paclitaxel interferes with the normal function of microtubules, which are structures that help cells divide. This action helps to kill cancer cells or slow their growth.

What is already known about the treatment

Ramucirumab
This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating advanced stomach cancer, specifically stage IV with metastases. It is used as a second-line treatment option, either alone or in combination with another drug called paclitaxel. Ramucirumab works by blocking a specific protein that helps cancer cells grow new blood vessels, which are necessary for tumor growth. It is classified as a monoclonal antibody, a type of targeted cancer therapy.
Paclitaxel
This medication is also administered intravenously and is being evaluated in combination with ramucirumab for treating advanced stomach cancer. It is used as a second-line treatment to improve survival and quality of life in patients. Paclitaxel works by interfering with the normal function of microtubules during cell division, which prevents cancer cells from multiplying. It is classified as a chemotherapy drug, specifically a taxane, which targets rapidly dividing cancer cells.

Investigated diseases

Stomach Cancer Stage IV with Metastases – This is an advanced form of cancer that originates in the stomach and has spread to other parts of the body. At this stage, the cancer cells have moved beyond the stomach lining and invaded nearby organs or distant sites such as the liver, lungs, or lymph nodes. The disease often progresses rapidly, with symptoms that may include severe abdominal pain, weight loss, and difficulty eating. As the cancer spreads, it can lead to complications such as blockages in the stomach or intestines and fluid accumulation in the abdomen. The progression of the disease can vary, but it typically involves increasing severity of symptoms and further spread of cancer cells.