Clinical Trials

The Pancreatic Cancer Action Network’s Patient and Liaison Services (PALS) program, in partnership with EmergingMed, maintains a comprehensive and up-to-date pancreatic cancer clinical trials database. Information about these clinical trials is available to the public at no charge. To access this information or for other questions related to pancreatic cancer, contact a PALS Associate toll free at 877-272-6226 or email pals@pancan.org. PALS Associates are available M-F 7am-5pm Pacific Time.

What are clinical trials?
Clinical trials are research studies that investigate treatments and observe patient performance with new treatments.  They play an important role in developing new treatment options for a variety of diseases, including pancreatic cancer.  Before any new treatment can be tested in humans, it must have shown positive results in the laboratory and/or in animal studies.

Pancreatic cancer clinical trials are necessary to determine whether new treatments developed in the laboratory are beneficial to people living with pancreatic cancer.  The United States Food and Drug Administration (FDA) monitors most clinical trials to protect the participants and the general public.  Ultimately, the FDA reviews and analyzes data from successful clinical trials to determine whether the experimental treatment should be approved for the treatment of a specific disease or disorder, such as pancreatic cancer.

Clinical trials may be carried out using completely new treatment options or using treatments that are already available.  Since all cancers are different, a drug that is already approved by the FDA for the treatment of one type of cancer may not be approved to treat pancreatic cancer.  In order for any pancreatic cancer therapy to be approved, it must pass through the clinical trial process involving patients who have pancreatic cancer.  Clinical trials are the safest and quickest way to confirm whether new treatments are truly beneficial for patients.

Why are clinical trials important?
Clinical trials offer a look at future treatments that may one day be available for all individuals who are diagnosed with pancreatic cancer.  They determine whether a new and potentially better treatment is safe and effective in humans.  Clinical trials may provide opportunities for patients to receive a promising drug or treatment.  A clinical trial may offer what the doctor feels is the best available treatment for the patient since new therapies are typically compared to currently approved treatments.

The currently approved drugs to treat pancreatic cancer were approved after showing their effectiveness and safety through clinical trials.  In 1996, the intravenous chemotherapy drug gemcitabine (Gemzar®) completed the clinical trial process and was approved by the FDA as the standard of care for pancreatic cancer.  Prior to gemcitabine, fluorouracil (5-FU) was used as the standard of care.  Both of these chemotherapy drugs are still used today.  In November 2005, the FDA approved an oral targeted therapy drug called erlotinib (Tarceva®), for use in combination with gemcitabine (Gemzar®) to treat advanced pancreatic cancer that cannot be removed surgically.  Clinical trials are currently in progress to study additional drugs, drug combinations, and other treatments for pancreatic cancer.

Safety and Informed Consent
Receiving safe and effective treatment is the goal for both clinical trial participants and for the researchers who provide the treatment.  In order to participate in any clinical trial, the FDA requires that an individual read and sign an informed consent form.  Informed consent is a process required by the FDA that ensures patients are given complete information about a clinical trial prior to their participation.  The key facts of the study are included in a written informed consent form for participants to read and discuss with their families and doctors.

Benefits and Risks of Clinical Trials
Potential Benefits:

• Possibility that drugs or treatment program used in the trial will be better than currently approved treatment options
• Care provided by top doctors and researchers at leading health care facilities
• Access to new treatment strategies that may not otherwise be available
• Closer monitoring of the patient
• Help to advance treatment of the disease

Potential Risks:

• Possibility of unknown or unexpected side effects
• Chance that the new drug or treatment may be ineffective or less effective than current options for pancreatic cancer
• May require greater time commitment for treatment due to extra clinic visits for treatments or monitoring
• Additional cost may be involved (i.e., housing and transportation, insurance payment for treatment outside covered network)

Finding and Enrolling in a Clinical Trial
Each clinical trial has separate enrollment guidelines that must be met by each patient in order to participate.  Generally, participants must meet a list of standard requirements such as type and stage of disease, prior treatments received, age, medical history, and current medical condition.  The purpose of these criteria is to identify a patient population with enough in common to be able to determine whether or not the treatment helped.

Clinical trials can increase the number of treatment options available to people diagnosed with pancreatic cancer.  Specific trials may not be conducted in every city.  However, resources are available to help locate the nearest suitable trial sites.  Since participating in a clinical trial is an important decision, patients should work with their doctors and healthcare teams to determine whether taking part in a clinical trial is appropriate.

The Pancreatic Cancer Action Network’s Patient and Liaison Services (PALS) program, in partnership with EmergingMed, maintains a comprehensive and up-to-date pancreatic cancer clinical trials database.  Information about these clinical trials is available to the public at no charge.  To access this information or for other questions related to pancreatic cancer, contact a PALS Associate toll free at 877-272-6226 or email pals@pancan.org.  PALS Associates are available M-F 7am-5pm Pacific Time.

Click here for additional resources for finding clinical trials on the internet. 
This list may not be comprehensive. 

The Pancreatic Cancer Action Network does not endorse any particular trial.

The information and services provided by the Pancreatic Cancer Action Network, Inc. are for informational purposes only.  The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment.  If you are ill, or suspect that you are ill, see a doctor immediately!  The Pancreatic Cancer Action Network does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.  080923