Current trials open to patient accrual
at: At the Florida Hospital Cancer Institute (FHCI)
|A PHASE 2 MULTICENTER SINGLE ARM CLINICAL TRIAL OF ABX-EGF
MONOTHERAPY IN SUBJECTS WITH METASTATIC COLORECTAL CANCER
FOLLOWING TREATMENT WITH FLUROPYRIMIDINE, IRINOTECAN AND
OXALIPLATIN CHEMOTHERAPY Colon Cancer
|| ABX-EGF 20030167
|A PHASE 2 MULTICENTER SINGLE ARM CLINICAL TRIAL OF ABX-EGF
MONOTHERAPY IN SUBJECTS WITH METASTATIC COLORECTAL CANCER
WHOSE TUMORS EXPRESS LOW OR NEGATIVE EGFR LEVELS BY IMMUNOHISTOCHEMISTRY
FOLLOWING TREATMENT WITH FLUOROPYRIMIDINE, IRINOTECAN,
AND OXALIPLATIN CHEMOTHERAPY
|A PHASE II MULTICENTER STUDY OF ERBITUX (CETUXIMAB)
IN PATIENTS WITH REFRACTORY, EGFR-NEGATIVE METASTATIC
|Breast Cancer A RANDOMIZED, OPEN-LABEL, CONTROLLED, CLINICAL
TRIAL OF CHEMOTHERAPY AND BEVACIZUMAB WITH AND WITHOUT
PANITUMUMAB IN THE FIRST-LINE TREATMENT OF SUBJECTS WITH
METASTATIC COLORECTAL CANCER
| RANDOMIZED, THREE ARM MULTINATIONAL PHASE III STUDY
TO INVESTIGATE BEVACIZUMAB (Q3W OR Q2W) IN COMBINATION
WITH EITHER INTERMITTENT CAPECITABINE PLUS OXALIPLATIN
(XELOX) (Q3W) OR FLUOROURACIL/LEUCOVORIN WITH OXALIPLATIN
(FOLFOX-4) VERSUS FOLFOX-4 REGIMEN ALONE AS ADJUVANT CHEMOTHERAPY
IN COLON CARCINOMA
Please read the frequently asked questions which provide
introductory information about clinical trials. In addition,
it is often helpful to talk to a physician, family members,
or friends about deciding to join a trial.
Below are questions that are frequently
asked regarding a clinical trials program.
A clinical trial is a research study
designed to evaluate potential, new treatment options. These
studies are the result of a long and deliberate cancer research
process that often takes years. Clinical trials test the safety
and effectiveness of new or modified cancer drugs, new drug
doses, unique approaches to surgery or radiation therapy,
and varied combinations of treatments.
For some people, a clinical trial implies experimentation
or being a guinea pig. However, as with any fear of the unknown,
understanding the process can ease your anxieties and equip
you with the knowledge you need to make an informed decision
about whether to participate in a clinical trial.
Patients who participate in a clinical trial receive either
a promising new treatment being tested or the best available
conventional treatment. And, while there is no guarantee that
any treatment will be successful, prior clinical trials have
proved to be some of the most effective treatments currently
in use for cancer today.
What are the benefits to taking part in
a clinical trial?
Most patients choose to participate in a clinical trial with
a desire of finding a better treatment or cure. While there
are no guarantees, researchers hope that the treatment options
offered through clinical trials will be comparable or better
than current standard care. If a new treatment option is proven
to work, and you are participating in the clinical trial,
you will be among the first to benefit.
Other benefits include:
- Access to state-of-the-art treatment for certain types
- Dedicated attention from a research nurse who attends
all treatment, follow-up and care associated with the clinical
trial in the physician’s office
- Direct contribution to finding better ways to prevent,
detect or treat cancer
How do clinical trials work?
Clinical trials are designed to test treatments under very
specific scientific and ethical guidelines. Each study follows
a precise action plan (protocol) that explains the number
of people that will participate in the study, who is eligible
to participate, what study drugs participants will take, what
medical tests will be administered and how often, and what
information will be gathered. The Florida Hospital Cancer
Institute (FHCI) uses the same research protocol as all other
research centers participating in a particular study.
Clinical trials are conducted in the physician’s office
and occasionally in the hospital. When the physician has identified
a clinical trial as an appropriate treatment option, a Clinical
Research Center registered nurse is notified to determine
the patient’s eligibility for the trial. The specific
type or stage of cancer usually determines eligibility, as
well as other factors.
Once eligibility is established, the research nurse will
explain the informed consent process. Informed consent is
one of the patient’s most important rights in the research
process, as it outlines the purpose of the study, the exact
treatments that will be administered, all possible side effects,
and the patient’s right to withdraw from the study at
any point. Signing the consent form acknowledges that the
trial was explained and is understood.
What clinical trial safeguards are in place?
Both standard care and clinical trials have risks, side effects
and benefits that vary depending on the individual. However,
there are rigorous guidelines in place to protect the well-being
and safety of clinical trial participants. The physician and
research nurse conducting the study will explain any known
or anticipated risks ahead of time. This information is contained
in the informed consent form as well. Also, clinical trial
participants are monitored closely to identify any changes
in their condition.
What is giving consent to participate in
a clinical trial?
Because every clinical trial is designed to answer a specific
research question, each clinical trial can only enroll patients
with certain types and stages of cancer. Your overall health
may also be a factor in whether you are an appropriate candidate
for a particular clinical trial.
The procedures that help us determine if a specific patient
volunteer is appropriate for a particular clinical trial also
provides the patient with information to help them decide
whether they wish to volunteer for the clinical trial. Your
medical records are examined, and your study physician reviews
them with you to obtain an appropriate medical history. You
will also have a physical exam and possibly other tests such
as blood work, x-rays, and other types of scans. The clinical
trial team then reviews your medical history and the results
of your exams and tests. From this, they decide if you are
an appropriate candidate for the clinical trial, meeting all
If you are not found to be eligible for a specific clinical
trial, you should not necessarily feel that there is anything
wrong with you. This only means that you do not meet all the
specific requirements for that particular clinical trial.
In many cases, patients do not qualify for clinical trials
because they are actually too healthy, or their disease is
not advanced enough.
If you are found to be eligible and meet all of the criteria,
the clinical trial team will then discuss with you and your
family the purpose of the clinical trial and what it involves.
They will explain the experimental plan that must be followed
carefully and any approved treatments available to you.
You will receive a consent form that must be signed before
you enter or start the trial. Before you sign the consent
form, you should review the form and discuss it with your
family and friends. It is important that you write down any
questions that you have and discuss them with your study doctor
or nurse before you sign it, keeping in mind that your signature
does not relinquish your right to discontinue participation
in the clinical trial at any time you wish. After you have
signed the consent form, you will be given a copy for your
The consent form contains information about the experimental
treatment, known side effects and risks, possible benefits,
potential costs and payments, and alternative treatments.
The consent form will also include information about whether
you will need to be hospitalized specifically for the clinical
trial, how long the trial lasts, the frequency of study visits,
and other important issues.
Participation in a clinical trial is completely voluntary.
It is your decision. You may decide to stop participation
at any time during the clinical trial. All clinical trial
personnel will support whatever choice you make. Choosing
not to participate in or withdrawing from a clinical trial
will not affect your ability to receive regular treatment.
Making a decision to participate in a clinical trial takes
time and careful consideration. It requires a commitment from
you and your family or friends to help ensure that you have
been properly informed of all information.
What other concerns should I have?
It is not unusual to have some fears or concerns about participating
in a clinical trial. Many patients worry that they will become
a “guinea pig” or “just another subject
number”. Patients in clinical trials receive the same
level of care from doctors and nurses as patients not participating
in clinical trials. However, patients on clinical trials are
often more closely monitored and may undergo more frequent
testing and exams to help evaluate the progress of their health
and their disease. Patients regularly receive information
about their condition and test results from their study doctor
and nurse. They continually learn about their disease, its
treatment, and ways to help themselves.
Patients in our clinical trials are monitored by nurses who
are the clinical coordinators for the trials. They ensure
that the clinical trial tests and examinations are scheduled
and completed, and that the test results and any side effects
are documented. They can discuss all aspects of the study
with you before, during, and even after the trial. The clinical
coordinator works closely with all other clinical trial personnel
to plan your care and procedures, and will probably provide
you with a calendar so that you can remember when you are
scheduled for study visits and tests. If you are giving yourself
medications at home that are part of the clinical trial, you
may also be given a diary card on which to record these medications
and any side effects that may occur.
Finally, patients with cancer and their families and friends
often have mixed emotions. They may feel anger, sadness, fear
of the future, nervousness, etc. Oncology nurses, doctors,
psychologists, and social workers understand this. They can
help give you and your family emotional support before, during,
and after the clinical trial.
What about confidentiality?
Information that is learned about any individual participating
in a clinical trial is confidential. Specific study sponsors
(e.g., research institutions, universities, or pharmaceutical
companies) and monitors from those sponsors may review your
medical records to ensure that clinical trial guidelines are
being followed. Any information that is reported to the sponsor
about your case will not identify you by name. Generally,
only the results of the whole group of patients on the clinical
trial are reported. The results of the clinical trial, however,
will be shared with health care professionals and other researchers
so that the findings can be used to help treat other people
with cancer or advance additional research efforts.
Who pays for the clinical trial?
Most treatment received in a clinical trial is considered
normal standard of care. Not all health insurance and managed
care providers cover all patient care costs in a study. However,
non-FDA-approved drugs used in clinical trials and extra tests
which would not normally be done, are provided at no cost
to study participants.
Where is treatment given?
Patients enrolled in clinical trials may receive their experimental
- a Clinical Research Unit
- a department in a hospital or cancer center
- a doctor's office
- a combination of these locations
Care is provided by oncologists and oncology nurses. Certain
procedures of some clinical trials also may be carried out
by the doctor who referred you.
What questions should you ask?
Your health care team wants to make certain that you have
all the information you need before and during your participation
in a clinical trial. Please share your questions or concerns
with your doctor and nurse. You may even wish to print and
take this list of questions with you to your next appointment.
- What is the purpose of the study? In what phase is this
- Who sponsors the study, and who has reviewed and approved
- How is the study data and patient safety being checked?
- When and where will study results and information go?
Possible Risks and Benefits
- What are the possible short- and long-term risks, and
- What are the possible benefits to me?
- Are there standard treatments for my type of cancer?
- How do the possible risks, side effects, and benefits
in the study compare with standard treatment?
- What kinds of experimental treatments, medical tests,
or procedures will I have during the study? Will they be
painful? How do they compare with what I would receive outside
- How often and for how long will I receive the experimental
treatment, and how long will I need to remain in the study?
Will there be follow-up after the study?
- Where will all procedures take place? Will I have to be
in the hospital? If so, how often and for how long? Can
a family member or friend stay with me during study visits?
- How will I know if the experimental treatment is working?
- Will I be able to see my own doctor? Who will be in charge
of my care?
- How could the study affect my daily life?
- Can you put me in touch with other people who are in
- What support is there for me and my family in the community?
- Will I have to pay for any of the experimental treatment,
tests, or other charges?
- What is my health insurance likely to cover?
- Who can help answer any question from my insurance company
or managed care plan?