Active not recruitingPHASE2INTERVENTIONAL

A Study of Olaparib Prior to Surgery and Chemotherapy in Ovarian, Primary Peritoneal, and Fallopian Tube Cancer

This study is investigating a new drug called olaparib. It's being tested for women with ovarian, primary peritoneal (a type of cancer similar to ovarian cancer), or fallopian tube cancer that has come back. The main idea is to give olaparib before surgery and chemotherapy, a treatment approach known as 'neoadjuvant treatment'. Researchers want to see if olaparib can help shrink the tumours before the main treatment, potentially making surgery more effective. Olaparib works by targeting a specific protein in cancer cells that helps repair their DNA. By blocking this protein, it might stop cancer cells from growing or even kill them. This is a Phase 2 trial, meaning it's still an early stage of testing, but it's looking promising.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

University Health Network, Toronto

Enrolment target

Start

19 Jul 2016

Estimated completion

31 Dec 2027

Ovarian Cancer Fallopian Tube Cancer Neoadjuvant Treatment Debulking Surgical Procedures

What is this study about?

This study is about exploring a new way to treat certain gynaecological cancers that have returned. Specifically, it's for women who have had ovarian, primary peritoneal (which develops in the lining of the abdomen, similar to ovarian cancer), or fallopian tube cancer, and the cancer has unfortunately come back. The main focus is on a drug called olaparib, which is a new type of cancer medicine.

Usually, when cancer comes back, treatment might involve surgery or chemotherapy. However, this study is looking at giving olaparib *before* these main treatments. This approach is called 'neoadjuvant treatment' and the idea behind it is to try and shrink the tumour first. If the tumour is smaller, it might make surgery easier and more successful, potentially leading to better outcomes for patients.

Olaparib works by targeting a specific protein inside cancer cells called PARP. PARP helps to fix damaged parts of the cancer cells' DNA. By blocking this PARP protein, olaparib can stop the cancer cells from being able to repair themselves properly, which can make them stop growing or even die. This study aims to understand how effective and safe this strategy is when used before surgery and chemotherapy.

Key takeaways

This study explores a new treatment approach for recurrent ovarian, primary peritoneal, or fallopian tube cancer.
Olaparib is a new drug given before surgery and chemotherapy to try and shrink tumours.
It works by blocking a protein (PARP) that helps cancer cells repair themselves.
This is a Phase 2 study, meaning it's an early but promising trial.
Participation involves taking olaparib, regular visits, and standard follow-up after surgery and chemotherapy.

Who may be eligible?

This study is looking for women aged 18 or over who have a specific type of ovarian, primary peritoneal, or fallopian tube cancer that has returned. Your doctors must have confirmed the cancer type with a biopsy, and they need to be able to take another biopsy before you start the study. Importantly, your cancer should be suitable for surgery, and you should have responded well to platinum-based chemotherapy in the past, with at least six months passing since your last treatment.

To join, you also need to be generally well enough to take part, with good overall health and organ function. If you could become pregnant, you'll need to agree to use effective contraception throughout the study. You must also be willing to follow the study schedule, attend appointments, and take the medication as instructed.

There are some reasons why you wouldn't be able to join. For example, if you've had a bad allergic reaction to olaparib or similar drugs, or to platinum chemotherapy in the past. You also can't have had radiation treatment or other cancer drugs (including another PARP inhibitor) in the last four weeks. If you have another serious medical condition that isn't under control, can't swallow pills, or are taking certain other medications, you might also not be able to participate. Your doctors will carefully check all these requirements.

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.

Is your cancer ovarian, primary peritoneal, or fallopian tube cancer that has returned?
Are you 18 years old or older?
Have your doctors confirmed that your cancer is suitable for surgery?
Have you responded well to previous platinum-based chemotherapy?
Are you generally well enough for a clinical study, with no other major uncontrolled health problems?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be given olaparib to take before your planned surgery and chemotherapy. You'll have regular appointments with the study team, including physical examinations, blood tests, and scans, to monitor your health and how you're responding to the treatment. These are important for checking the drug's effects and making sure it's safe for you. You'll need to take the study medication as prescribed and attend all scheduled visits and tests. The total duration of your participation will vary depending on your treatment plan, but it will involve taking olaparib for a period before your surgery, followed by your usual chemotherapy, and then regular follow-up checks to keep an eye on your progress and health over time.

Potential risks and benefits

Participating in this study might offer potential benefits, as olaparib could help shrink your tumour before surgery, potentially making your treatment more effective. However, like all medicines, olaparib can have side effects, which your doctor will explain in detail. There might also be side effects from the study procedures, such as blood tests. It's important to know that you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (9)

Tom Baker Cancer Centre
Verified postcode
Calgary, Canada
Ottawa Regional Cancer Centre
Verified postcode
Ottawa, Canada
Princess Margaret Cancer Centre
Verified postcode
Toronto, Canada
Centre hospitalier de l'Université de Montréal (CHUM
Verified postcode
Montreal, Canada
Jewish General Hospital
Verified postcode
Montreal, Canada
Auckland City Hospital
Verified postcode
Grafton, New Zealand
Vall d'Hebron University Hospital
Verified postcode
Barcelona, Spain
Royal Marsden Hospital NHS Foundation Trust
Verified postcode
London, United Kingdom
Imperial College Healthcare NHS Trust
Verified postcode
London, United Kingdom

Common questions

What is olaparib?

Olaparib is a new type of drug that works by blocking a protein in cancer cells, which can stop them from growing or cause them to die.

Why is it given before surgery and chemotherapy?

The idea is that giving olaparib first might shrink your tumour, making surgery easier and potentially more successful.

What kind of cancer is this study for?

This study is for women with ovarian, primary peritoneal, or fallopian tube cancer that has returned after previous treatment.

Will I still have surgery and chemotherapy?

Yes, olaparib is given *before* your surgery and chemotherapy, which are still part of your main treatment plan.

Is olaparib a chemotherapy drug?

No, olaparib works in a different way to traditional chemotherapy by targeting specific processes within cancer cells.