CompletedPhase IIInterventional

A Phase II study of axitinib in patients with metastatic renal cell cancer unsuitable for nephrectomy

This trial investigates a targeted cancer medicine called axitinib for people with advanced kidney cancer. It focuses on patients whose cancer has spread to other parts of the body (metastatic kidney cancer) and who are unable to have surgery to remove the affected kidney. Usually, surgery is a common first step, but it is not safe or suitable for everyone. When surgery is not an option, doctors need effective medicines to help manage the disease. Axitinib works by blocking signals that cancer cells need to grow and form new blood vessels. Participants take axitinib as a tablet and have regular hospital visits, blood tests, and scans so doctors can monitor their health and check if the treatment is helping. This study aims to find out if giving axitinib early can slow down tumour growth and help patients live well for longer.

At a glance

Status

Completed

Phase

Phase II

Sponsor

Institute of Cancer Research (UK)

Enrolment target

Start

28 Sep 2012

Estimated completion

27 Sep 2014

Renal cancer

What is this study about?

Kidney cancer begins when abnormal cells in the kidney grow out of control. In some cases, the cancer spreads to other areas of the body, which doctors call advanced or metastatic kidney cancer. Usually, a key part of treatment is an operation to remove the kidney. However, for many patients, having surgery is not safe or possible because of where the tumour has spread or due to general health issues.

This Phase 2 clinical trial is exploring whether a targeted medicine called axitinib can help people in this situation. Axitinib comes as a tablet that you swallow. It belongs to a family of drugs that cut off the blood supply to cancer cells. Without new blood vessels, tumours struggle to get the nutrients and oxygen they need to grow.

Finding effective treatments for people who cannot undergo surgery is vital. By testing axitinib in patients who have not yet had other drug therapies, doctors hope to learn if this medicine can shrink tumours, delay the cancer from worsening, and maintain a good quality of life.

Key takeaways

Tests the targeted drug axitinib for advanced clear cell kidney cancer.
Aimed at people whose cancer has spread and who cannot have kidney surgery.
Open to patients who have not yet had drug treatment for kidney cancer.
All participants receive the real study drug (no dummy pills are used).
Requires regular clinic check-ups, scans, and blood tests to monitor your health.

Who may be eligible?

This trial is for adults aged 18 and over who have been diagnosed with advanced 'clear cell' kidney cancer that has spread to other parts of the body. To be eligible, your medical team must agree that surgery to remove your kidney is not suitable for you, and that starting treatment promptly is better than taking a 'watch and wait' approach.

You must not have had any previous drug treatments (such as targeted therapies or immunotherapy) for your kidney cancer. You also need to be reasonably active and well enough to carry out daily tasks, with satisfactory blood test results showing that your liver, kidneys, and bone marrow are working safely.

You cannot take part if the cancer has spread to your brain, unless it has been treated and remained completely stable for at least six months. Your blood pressure must also be well controlled (either naturally or with blood pressure tablets), and women who could become pregnant must have a negative pregnancy test before starting.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am aged 18 or older.
I have advanced clear cell kidney cancer that has spread.
My specialist has confirmed that surgery to remove my kidney is not an option.
I have not had any previous drug treatments for my kidney cancer.
I am well enough to be up and about for light daily tasks.
My blood pressure is normal or well managed with medication.

Answer every question to see your result.

What does participation involve?

If you take part, you will be prescribed axitinib tablets to take at home every day. You will need to attend hospital visits regularly, especially during the first few months, so the study team can monitor your health. These visits will involve blood pressure checks, blood and urine tests, and questions about any side effects you may have. You will also have regular imaging scans, such as CT scans, every few months to check whether the tumour is shrinking or staying stable. The trial may also involve taking a small tissue sample (biopsy) of the tumour. You will usually stay on the study medication for as long as it continues to control the cancer and the side effects remain manageable. You are free to stop treatment at any time.

Potential risks and benefits

A potential benefit of joining this study is that axitinib may shrink your tumours or slow down the cancer, although this cannot be guaranteed. The study also helps doctors learn more about treating kidney cancer without surgery, which could benefit others in the future. However, there are potential side effects, including high blood pressure, tiredness, diarrhoea, feeling sick, and changes to your voice or skin. The medical team will check you frequently to manage these issues. Taking part is entirely voluntary, and you have the right to withdraw at any stage without it affecting your standard NHS care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Institute of Cancer Research Clinical Trials & Statistics Unit (ICR-CTSU)
City only
Sutton, England

Common questions

What is axitinib and how is it taken?

Axitinib is a targeted cancer drug that blocks the blood vessels tumours need to grow. It is a tablet that you swallow with water, usually taken twice a day.

Will I receive a dummy pill (placebo)?

No. In this trial, every participant receives the active study medicine, axitinib. There is no placebo.

How often will I need to visit the hospital?

Visits are more frequent during the first few weeks to make sure your dose is safe and your blood pressure is controlled. Once settled, visits usually happen once every few weeks.

Can I continue my normal daily activities?

Many people can manage their normal daily routines, but you may feel more tired than usual. Your care team will advise you on balancing rest and activity.

What happens if the treatment does not work for me?

If your scans show that the cancer is growing, or if you experience troublesome side effects, the study medicine will be stopped and your doctor will discuss alternative standard treatments.

How to find out more

Rebecca Lewis

apredict-icrctsu@icr.ac.uk - Official trial record

Always speak to your GP or specialist before deciding to take part in a study.