Trial Information

A Feasibility Study for Identifying the Role of Symptom Outcomes and Biomarkers in Survival in Patients With Metastatic Pancreatic Cancer

Researchers want to try to improve patient care for advanced pancreatic cancer by looking at
how some symptoms create a great burden on daily life. They also want to find out which
"markers" in the blood. Biomarkers are substances found in the blood, such as cytokines,
certain proteins, and DNA changes. These biomarkers may help doctors predict "symptom
burden" during therapy.

Researchers would also like to collect data about your physical function as part of this
study. If you agree to wear a pedometer, you will wear the pedometer every day for a month
during your waking hours. The pedometer used in the study is a small box that weighs less
than an ounce and is smaller than a deck of playing cards. It is used to measure the number
of steps you take during the day. Researchers will help you set the pedometer and show you
how to use it. You will also keep a diary to record your use of the pedometer during this
month. Researchers will meet with you during your clinic visits for chemotherapy at 2 weeks
and 4 weeks to collect the data.

If you agree to take part in this study, you will have the following 4 types of study
procedures performed:

Questionnaire:

Before chemotherapy that is scheduled by GI Medical Oncology Clinic starts, you will be
asked to complete a questionnaire during a visit to the clinic. The questionnaire will
measures physical and emotional symptoms. It should take about 5 minutes to finish. During
this visit, the research staff will also teach you how to use the telephone system for
measuring symptoms. You will tell the research staff the most convenient times for the
telephone calls each week and the system will be set up to call you at that time.

Blood Draws:

Before you begin your chemotherapy treatments, you will have a sample of blood drawn (around
3½ tablespoons). The sample of blood will be used to measure levels of cytokines
(biomarkers in the blood) and DNA (the genetic material in cells) in your blood before
treatment starts. These cytokines may be related to symptoms experienced while having
treatment for cancer.

You will have about 2½ tablespoons of blood drawn again when you complete first and second
cycle of chemotherapy, and then at 2 months and 4 months after the start date of
chemotherapy. Each blood sample will be drawn during your routine blood draw for continuing
chemotherapy.

Symptoms Review:

You will have a MDASI-GI symptom assessment face to face, by regular mail, or through the
phone calls. These will be used to measure symptom burden over time of the treatment and
after treatment. The assessments will be done weekly for up to 4 months and then twice a
month for up to an additional 14 months.

If your assessment is done by phone, it may be done by a study staff member or by using an
interactive voice response telephone system (IVRS). During the study, the automated
telephone system will call you once a week to ask you to rate your symptoms and how much the
symptoms get in the way of your daily life. The information collected by these calls is
only being used for this research study. This phone call should take about 5 minutes to
complete.

This is an investigational study. Up to 100 patients will take part in this study. All
will be enrolled at MD Anderson.