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Clinical studies in Ovarian Cancer

Frequently asked questions

This page provides answers to some commonly asked questions about ovarian cancer, clinical studies, and olaparib, which patients, their relatives, friends, or carers may find useful.

The body is made up of a vast number of different cells.  It is important for cells to grow and divide when we are young so that our bodies grow.  Cells can also grow and divide throughout life, to replace old cells or to repair damage from injuries.  Normally, cells grow, divide, and die in a controlled manner.  Cancer forms when cell growth becomes out of control.

Ovarian cancer is cancer of the ovaries, the reproductive glands in women that produce eggs.  There are three main types of ovarian tumor:

  • Epithelial tumors
    • These are tumors that start from the epithelial cells, which are the cells that form the surface of the ovaries.  Epithelial tumors are the most common type of ovarian cancer
  • Germ cell tumors
    • These tumors form from germ cells in the ovaries, which are the cells that form the eggs (ova)
  • Stromal tumors
    • These tumors start from stromal cells, the structural cells which hold the ovaries together and produce female hormones

Many ovarian tumors are benign (non-cancerous).  However, some ovarian tumors are malignant (cancerous) and can spread to other parts of the body (metastasize).

Ovarian cancer can be divided into four stages:

  • Stage 1
    • the cancer is confined to one or both ovaries
  • Stage 2
    • the cancer is in one or both ovaries and has spread into the pelvic tissues (eg the uterus and/or fallopian tubes)
  • Stage 3
    • the cancer is in one or both ovaries and has spread to the peritoneum (the lining of the abdomen) and/or the lymph nodes
  • Stage 4
    • this is advanced ovarian cancer.  The cancer has spread to more distant locations such as inside the liver, lungs, or other organs located outside the abdominal area

Symptoms of ovarian cancer include:

  • Bloating
  • Pelvic pressure or abdominal pain
  • Difficulty eating or feeling full quickly
  • Urgent or frequent urination

However, many of the symptoms of ovarian cancer are similar to less serious conditions such as Irritable Bowel Syndrome (IBS), and in the early stages, ovarian cancer often causes few or no symptoms.

Treatment options vary depending on the stage of the cancer but usually involve a combination of surgical removal and platinum-based chemotherapy, which can delay the progression of ovarian cancer.

  • Surgery has two purposes; to determine what stage the cancer is at and how far it has spread, and to remove as much of the cancer as possible
  • Chemotherapy is a systemic treatment, meaning the medications enter the bloodstream and reach all parts of the body.  Systemic treatment is useful for cancers that have spread to more distant sites

Approximately 80% of women with ovarian cancer will relapse after their first course of treatment with chemotherapy.

Scientists are investigating new ovarian cancer treatments called ‘targeted therapies’.  Unlike chemotherapy, which also has effects on normal cells, targeted therapies specifically attack cancerous cells.  One such treatment is Avastin® (bevacizumab), which works by stopping cancer cells from forming the new blood vessels that provide them with nutrients, helping them grow and spread.  The PARP inhibitor olaparib has already been approved by the Food and Drug Administration (FDA) for the treatment of women with inherited BRCA mutations with advanced ovarian cancer, who have previously received three or more courses of chemotherapy; however, it is still under investigation as a targeted therapy in the treatment of different types of ovarian cancer.  Radiation therapy and hormone therapy are also used to treat ovarian cancer.

Ovarian cancer is the ninth most common cancer in women (excluding non-melanoma skin cancers).  During their lifetime, one out of 75 women will get ovarian cancer and it is the fifth most common cause of death from cancer in women.  Ovarian cancer is more common in older women, with around half of the cases being diagnosed in women who are 63 years or older.

A clinical study (or clinical trial) is a scientific investigation of possible new medications or of different versions or new uses of existing medications.  A clinical trial for ovarian cancer can help find out whether a potential new medicine works against the cancer.

Each study is regulated and reviewed by regulatory and ethical groups before it can begin.  In one year, an estimated 2.3 million patients took part in such carefully conducted trials in the United States.  Systems are in place to ensure your personal and medical data are protected.

New medications must go through several phases of clinical testing to determine how well they work and how safe they are; the SOLO3 study is a Phase 3 trial in ovarian cancer, which means that it is a large-scale trial that is being conducted following positive results in smaller-scale studies.

Further information about ovarian cancer clinical trials can be found on these websites:

Olaparib is an investigational treatment for ovarian cancer that is not like chemotherapy.  Olaparib has been approved by the Food and Drug Administration (FDA) for the treatment of women with inherited BRCA mutations with advanced ovarian cancer, who have previously received three or more courses of chemotherapy; however, it is still being tested to see whether it works in the treatment of different types of ovarian cancer.  Olaparib is a PARP inhibitor which means it works by stopping a protein called PARP from working properly. PARP is a new target in ovarian cancer research and is short for ‘poly (ADP-ribose) polymerase’.  In cancer cells, PARP repairs the DNA of genes that have been damaged by chemotherapy, allowing the cancer cells to multiply and the tumor to get bigger. Since olaparib stops PARP from working, the cancer should stop growing or shrink if the treatment works.

A gene is a section of DNA carrying information that is transferred from one generation to the next.  Changes in some genes, known as ‘mutations’, can be linked with certain diseases that are inherited.  The BRCA genes are implicated in some breast and ovarian cancers. Around one in 10 women with ovarian cancer has changes in their BRCA genes. Family members who inherit mutations in their BRCA1 genes have an average risk of 35-70% of developing ovarian cancer during their lifetime, whereas family members who inherit mutations in their BRCA2 genes have an average risk of 10-30% of developing ovarian cancer by the time they are 70 years old.  Women who test positive for a certain mutation in their BRCA1 or BRCA2 genes are often referred to as being BRCA positive.  A previous clinical study in ovarian cancer has shown that olaparib worked best in women with mutations in their BRCA1 and BRCA2 genes.  One of the aims of the SOLO3 study is to try and confirm these results in a larger group of women who have inherited BRCA mutations.

Some women with ovarian cancer will already know whether they have faulty BRCA genes from being tested previously, but others may not.  Everyone in the SOLO3 study will have their BRCA status tested, even women who have already been tested before.  Your doctor will take a sample of your blood to test for inherited BRCA mutations.  This will be sent to a laboratory where your BRCA genes can be analyzed.  Because changes in the BRCA genes tend to run in families, if you do not know your BRCA status, you should discuss testing with your doctor or a genetics expert to understand the conversations you may want to have with family members if the test is positive, as your children will have a 50% chance of inheriting this mutation from you.  Women who test positive for inherited BRCA mutations are eligible to participate in the SOLO3 study.

A clinical study of olaparib in women who:

  • Have previously been diagnosed and treated for ovarian cancer, peritoneal cancer, and/or fallopian tube cancer and their disease has come back. This is termed ‘relapsed’ or ‘recurrent’ cancer
  • Have an inherited BRCA mutation
  • Have completed at least two courses of platinum-based chemotherapy, and finished the last course at least six months ago. Platinum agents are carboplatin, cisplatin, and oxalaplatin
  • Have a tumor that has shrunk or disappeared following their last course of platinum-based chemotherapy

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To understand whether olaparib helps women with ovarian cancer, it needs to be compared to another treatment.  In the SOLO3 study, olaparib will be tested against a single non-platinum-based chemotherapy treatment chosen by a doctor who is involved in the study.  A further course of platinum-based chemotherapy is normally used to treat women with relapsed ovarian cancer; however, non-platinum-based chemotherapy can be given to women instead depending on the circumstances.  In the SOLO3 study, a computer program randomly selects whether women joining the study will be given olaparib or chemotherapy (a process called ‘randomization’).  Women will be twice as likely to receive olaparib as chemotherapy because, for every three women in the study, two will receive olaparib and one will receive chemotherapy.

The women in the study and the doctors will know which treatment each woman is receiving, due to the different administration route and schedule, and different tolerability of each treatment.  Olaparib is taken by mouth twice daily, whereas chemotherapy is given intravenously between every week and every four weeks, depending on the chemotherapy chosen by the doctor.  Scans will be taken regularly to monitor the disease.  Scans will be taken regularly to monitor the course of the cancer and to help decide on future courses of treatment.

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