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Pancreatic cancer clinical study

Frequently asked questions

This page provides answers to some commonly asked questions about pancreatic cancer, clinical studies, and olaparib, which patients, their relatives, friends, or caregivers 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 can grow.  Cells also continue to 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.

The pancreas is an organ that produces enzymes which assist with food digestion and hormones, which include those that control blood-sugar levels.  There are two main types of pancreatic tumors that are very different from each other:

  • Exocrine tumors
    • These are tumors that start from the exocrine cells, which are the cells in the enzyme-producing region of the pancreas.  Exocrine tumors are the most common type of pancreatic cancer, and 95% of these tumors are pancreatic adenocarcinomas, which are the types of tumors that are being investigated in the POLO study
  • Endocrine tumors
    • These are tumors that start from the endocrine cells, which are the cells in the hormone-producing region of the pancreas.  Endocrine tumors account for less than 4% of pancreatic cancers, and can also be referred to as neuroendocrine or islet cell tumors

Some pancreatic tumors are benign (non-cancerous) or may develop into cancer if not treated (pre-cancerous).  However, some pancreatic tumors are malignant (cancerous) and can spread to other parts of the body (metastasize).

Pancreatic cancer can be divided into five stages:

  • Stage 0
    • The cancer is confined to the top layers of cells.  It has not invaded into deeper tissues or spread outside of the pancreas
  • Stage I
    • The cancer is confined to the pancreas and is 2 cm or less across (Stage IA)
    • The cancer is confined to the pancreas and is larger than 2 cm across (Stage IB)
  • Stage II
    • The cancer is growing outside of the pancreas, although not in major blood vessels or nerves (Stage IIA)
    • The cancer is either confined to the pancreas or it is growing outside of the pancreas, although not in major blood vessels or nerves.  The cancer has spread to lymph nodes that are nearby (Stage IIB)
  • Stage III
    • The cancer is growing outside of the pancreas into major blood vessels or nerves.  In addition, the cancer may have spread to lymph nodes that are nearby
  • Stage IV
    • The cancer has spread to more distant locations (metastasized)

Symptoms of pancreatic cancer are different depending on whether the tumors are exocrine or endocrine.  Exocrine tumors will be focused on here since only patients with pancreatic adenocarcinomas are eligible for the POLO study.  Symptoms of exocrine tumors include:

  • Jaundice (yellowing of the skin and the whites of the eyes, caused by a build-up of a substance called bilirubin) and symptoms relating to this
  • Back or abdominal pain
  • Poor appetite and weight loss
  • Problems with digestion, including nausea and vomiting, and changes in stools
  • Enlargement of the gall bladder
  • Blood clots
  • Abnormalities of fatty tissues
  • Diabetes

However, many of the symptoms of pancreatic cancer are similar to other conditions, and in the early stages, pancreatic cancer often causes no symptoms so can be difficult to detect.

Treatment options for pancreatic cancer can vary depending on whether or not the tumor can be removed by surgery.  The overall health of a person can also affect treatment.  The main treatment options for pancreatic cancer include:

  • Surgery which can have the aim of either removing all of the cancer (potentially curative) or relieving symptoms/preventing complications (palliative)
  • Radiation therapy which kills cancer cells using high energy X-rays or particles, and is mostly used for exocrine tumors
  • Chemotherapy which reaches all areas of the body, and can be used at any stage

New targets in pancreatic cancer have led scientists to investigate potential treatments for pancreatic cancer called ‘targeted therapies’.  Targeted therapies may be a new option for pancreatic cancer drugs.  Unlike chemotherapy, which also affects normal cells, targeted therapies specifically target changes (mutations) that have occurred in cancerous cells.  PARP inhibitors, such as olaparib, are currently under investigation to see if they also work as a targeted therapy in people with BRCA-mutated cancers including pancreatic cancer.

Pancreatic cancer is the 11th most common cancer in the USA and the fourth most common cause of death from cancer.  During their lifetime, a person’s average risk of developing pancreatic cancer is one in 67.  Pancreatic cancer accounts for approximately 3% of all cases of cancer in the USA, and 7% of cancer deaths are due to pancreatic cancer.  The risk of developing pancreatic cancer increases with age, and it is more common in men than in women.

Further information about pancreatic cancer, including details of support groups and information for caregivers or relatives of patients with pancreatic cancer, can be found at the websites below:

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

Each study is highly regulated and approved by regulatory and ethical groups before it can begin.  In 1 year, an estimated 2.3 million patients took part in such carefully conducted trials in the USA.  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 POLO study is a Phase 3 trial in metastatic pancreatic cancer, which means it is a large-scale trial that is being conducted following initial positive results in smaller-scale studies.

Clinical studies are the only way that researchers can develop new treatment options for people living with pancreatic cancer.  Many people are not aware of this option – currently only about 4.5% of all patients with pancreatic cancer enroll in clinical trials.  Increased participation would help with progress in the development of new treatments for pancreatic cancer.

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

Olaparib is an investigational medication for metastatic germline BRCA-mutated pancreatic cancer that is different from chemotherapy.  Olaparib has been approved by the Food and Drug Administration (FDA) for the treatment of women with germline BRCA genetic mutations with advanced ovarian cancer, who have previously received three or more courses of chemotherapy.  Olaparib is a PARP inhibitor which means it works by stopping a protein called PARP from working properly.  PARP is a new target in pancreatic cancer research.  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 DNA repair can no longer take place and the cancer might stop growing (stabilize) or shrink (improve) 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 hereditary diseases.  The BRCA genes are implicated in some breast and ovarian cancers.  In addition, BRCA mutations have been associated with other cancer types, including pancreatic cancer.  People with BRCA mutations have a 1–7% risk of developing pancreatic cancer during their lifetime.  A previous clinical study of olaparib in pancreatic cancer has shown that it worked in people with mutations in their BRCA1 or BRCA2 genes.

One of the aims of the POLO study is to try to confirm these results in a larger group of people who have BRCA mutations.

Almost one in every 20 people with pancreatic cancer has changes in their BRCA genes.  Some people with pancreatic cancer will already know whether they have these changes, but others may not.  Everyone in the POLO study will have their BRCA status tested, even people who have already been tested before.  Your doctor will take a sample of your blood.  This will be sent to a laboratory where your BRCA genes can be analyzed to see if there is a germline BRCA mutation.

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.

A clinical study of olaparib in people who:

  • Are at least 18 years of age
  • Have been clinically diagnosed with a type of pancreatic cancer known as adenocarcinoma that has spread outside of the pancreas (also known as metastatic pancreatic cancer)
  • Have an inherited germline BRCA genetic mutation (gBRCA1 or gBRCA2)
  • Have received one course (minimum of 16 weeks) of platinum-based chemotherapy, with the last dose completed 4–8 weeks before starting the study treatment. (Platinum agents include carboplatin, cisplatin, and oxaliplatin)
  • Have a tumor that has not grown (stabilized) or improved (shrunk/disappeared) during treatment with platinum-based chemotherapy
  • Have reached a point in their chemotherapy where both they and their doctor believe having a pause or break in chemotherapy treatment is appropriate

A placebo is a dummy medication or ‘sugar pill’ that looks exactly like the study medication but does not contain any active ingredients.  Sometimes, to find out if a medicine works it is compared with having no medicine at all, and a placebo is used to do this.  In the POLO study, a computer randomly selects whether people joining the study will be given olaparib or placebo (a process called ‘randomization’).  For every five people who take part in the POLO trial, three will receive olaparib and two will receive placebo.  So that people receiving olaparib and those receiving placebo are treated in the same way, it is important that nobody, including the people in the study, their doctors, and study nurses, know who is taking which treatment (this is known as the study being ‘double-blinded’).

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