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Study Comparing Olaparib and Chemotherapy for Patients with Recurrent Ovarian Cancer After Surgery

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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 the effects of a medication called olaparib in patients with recurrent ovarian cancer. The study compares the use of olaparib, which is taken as a tablet, to standard chemotherapy treatments that include medications such as paclitaxel, carboplatin, gemcitabine, doxorubicin, bevacizumab, and cisplatin. These chemotherapy drugs are typically given through an intravenous (IV) infusion.

The purpose of the study is to determine how effective olaparib is in maintaining the health of patients after their cancer has progressed, compared to the standard chemotherapy options. Participants in the study will receive either olaparib or one of the standard chemotherapy treatments after undergoing a surgical procedure known as secondary cytoreductive surgery, which aims to remove as much of the cancer as possible.

The study will follow participants over a period of time to observe their progression-free survival, which means the length of time during and after treatment that a patient lives with the disease without it getting worse. The study will also look at overall survival, safety, and quality of life. Participants will be randomly assigned to receive either olaparib or one of the standard chemotherapy treatments, and some may receive a placebo. The study is designed to provide valuable information on the best treatment options for patients with recurrent ovarian cancer.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initiation of treatment
Upon joining the study, the patient will begin treatment with olaparib in the form of film-coated tablets. The dosage will be either 150 mg or 100 mg, taken orally. The specific dosage and frequency will be determined by the study protocol and the patient's condition.
Step 2
Chemotherapy administration
The patient may receive chemotherapy drugs such as paclitaxel, carboplatin, gemcitabine hydrochloride, doxorubicin hydrochloride, bevacizumab, and cisplatin. These medications are administered intravenously, meaning they are given through a vein. The specific drugs and their dosages will be determined based on the patient's treatment plan.
Step 3
Monitoring and follow-up
Throughout the trial, the patient's health and response to treatment will be closely monitored. This includes regular check-ups and tests to assess the effectiveness of the treatment and to identify any side effects. The frequency and type of monitoring will be specified in the study protocol.
Step 4
Completion of treatment
The treatment phase will continue until the study's end date or until the patient completes the prescribed course of treatment. The estimated end date for the trial is December 31, 2026. Upon completion, the patient's overall health and treatment outcomes will be evaluated.

Who can join the trial?

20 criteria

Must sign a form agreeing to participate in the study.
Must be a female who is at least 18 years old.
Must have a type of cancer called **high-grade serous or endometroid ovarian, fallopian tube, or primary peritoneal cancer** that has come back or is getting worse after initial treatment.
Must have had only one previous treatment with a **platinum-containing regimen** (a type of chemotherapy). Treatments with a drug called **bevacizumab** are allowed.
Must have received a first-line maintenance therapy with a **PARPi** (a type of medication) for at least 6 months. If the medication used was **olaparib**, it should not have caused serious side effects or required a permanent dose reduction.
Must have had surgery to remove cancer that has come back. The surgery should have removed all visible cancer or at least the cancer that was growing during maintenance therapy.
Must have a known **BRCA1/2 status** (genes related to cancer risk). If the status is unknown, must agree to have it tested before joining the study.
Must have a life expectancy of at least 16 weeks.
Must start the study treatments within 3 to 8 weeks after the second surgery.
Must have an **ECOG performance status** of 0 to 1, which means being fully active or having some symptoms but still able to carry out light work.
Must provide samples from both the first and second surgeries for analysis.
Must be able to take medications by mouth.
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Must have normal organ and bone marrow function, which includes:
- **Hemoglobin** level of at least 10.0 g/dL without a blood transfusion in the past 28 days.
- **Absolute neutrophil count (ANC)** of at least 1.5 x 10⁹/L.
- **Platelet count** of at least 100 x 10⁹/L.
- **Total bilirubin** level of no more than 1.5 times the normal limit.
- **AST** and **ALT** levels of no more than 2.5 times the normal limit (or 5 times if there are liver metastases).
- **Creatinine clearance** of at least 51 mL/min, which measures kidney function.
- If not on blood thinners, **INR** or **aPTT** should be no more than 1.5 times the normal limit. If on blood thinners, specific ranges apply.
- Must be postmenopausal or have proof of not being able to have children, confirmed by a negative pregnancy test before starting the study.

Who cannot join the trial?

3 criteria

Patients who have not undergone secondary cytoreductive surgery for their recurrent or progressive ovarian cancer. This is a surgery to remove as much of the cancer as possible after it has returned or continued to grow.
Patients who are not female, as the study is only for women.
Patients who are part of a vulnerable population, meaning those who might need special protection or care, are not included in this study.

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Verified sites

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Responsive
Azienda Ospedaliera Ordine Mauriziano Di Torino
Turin, Italy
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Azienda Ospedaliero Universitaria Careggi
Florence, Italy
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Azienda Ospedaliero Universitaria Di Sassari
Sassari, Italy

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Investigated drugs

Olaparib is a medication used in this trial to see if it can help patients with recurrent ovarian cancer live longer without the disease getting worse. It is being tested to see if it works better than the usual chemotherapy after patients have had surgery to remove as much of the cancer as possible. Olaparib is a type of targeted therapy known as a PARP inhibitor, which works by preventing cancer cells from repairing themselves, leading to their death.

What is already known about the treatment

Olaparib – Olaparib is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating recurrent ovarian cancer, particularly after secondary cytoreductive surgery. The main therapeutic indication for olaparib is as a maintenance treatment to delay disease progression in patients with recurrent ovarian cancer. At the molecular level, olaparib works by inhibiting the enzyme poly (ADP-ribose) polymerase (PARP), which is involved in DNA repair. This inhibition leads to the accumulation of DNA damage in cancer cells, ultimately causing their death. Olaparib is classified as a PARP inhibitor in pharmacology.

Investigated diseases

Recurrent Ovarian Cancer – This disease occurs when ovarian cancer returns after a period of remission. It typically involves the reappearance of cancerous cells in the ovaries or other areas of the body after initial treatment. The progression of recurrent ovarian cancer can vary, with some patients experiencing slow growth of cancer cells, while others may have a more rapid progression. Symptoms may include abdominal pain, bloating, and changes in bowel habits. The disease often requires further medical intervention to manage its progression.