Clinical
Trials
Clinical trials are research
studies based on the treatment and observation of patients. 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 more effective 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 by 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 current 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 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 Monday through Friday from 8:00 am
to 5:00 pm Pacific Time.
This information has been
taken from Clinical Trials: Considering Participation in a Clinical
Trial, a booklet produced by the Pancreatic Cancer Action Network.
To receive a complimentary copy, please contact a Patient and Liaison
Services (PALS) Associate toll free at (877) 272-6226 or email pals@pancan.org.
You can also find pancreatic cancer clinical trials using the PALS
clinical trials database by clicking on the purple box below.
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The
following information lists additional resources for finding clinical
trials on the internet. This list may not be comprehensive.
PanCAN does not endorse any particular trial.
Federal
Agencies:
Click
here for a list of pancreatic cancer
clinical trials taking place at the National Institutes of Health
Click
here for a list of all NCI-supported
phase III cancer treatment trials in the U.S.
The
following are searchable databases of federally and privately supported
clinical research in all disease types including cancer.
www.ClinicalTrials.gov
www.Cancer.gov
Pharmaceutical Industry:
GenVec
1-888-344-6096
Eli
Lilly and Company 1-877-285-4559
NewLink
Genetics
Novartis
1-800-340-6843
Epeuis
Biotechnologies
Genentech
1-888-662-6728
Cooperative
Groups:
The
Coalition of Cancer Cooperative Groups
American
College of Surgeons Oncology Group (ACOSOG)
American
College of Radiology Imaging Network (ACRIN)
Southwest
Oncology Group (SWOG)
Eastern
Cooperative Oncology Group (ECOG)
North
Central Cancer Treatment Group (NCCTG)
Radiation
Therapy Oncology Group (RTOG) |
