Phase II Clinical Trial of Cisplatin + Gemcitabine in Combination With Mild, Fever-Range Whole-Body Hyperthermia to Treat Patients With Advanced, Inoperable Pancreatic Cancer

Trial Information

Phase II Clinical Trial of Cisplatin + Gemcitabine in Combination With Mild, Fever-Range Whole-Body Hyperthermia to Treat Patients With Advanced, Inoperable Pancreatic Cancer

The treatment cycle begins with 6 hours of intravenous (IV) hydration followed by an
infusion of the anti-cancer drug, Cisplatin. In addition, at the beginning of this
treatment, you will begin low-dose Interferon-alpha injections for the entire duration of
your participation in this study. The drug, Interferon-alpha, interrupts the division of
cancer cells, destroys tumor blood vessels, and slows tumor growth.

Forty-eight hours after the Cisplatin infusion, you will be treated with fever-range thermal
therapy (whole-body hyperthermia, or heat). When your core body temperature reaches 104oF
(40oC), a 30-minute (IV) infusion of another chemotherapy drug, gemcitabine (Gemzar) is
given. Cisplatin, low-dose Interferon-a and gemcitabine are the only chemotherapy drugs
used in this treatment plan. No other chemotherapy drugs are allowed to be given under this
treatment plan.

The fever-range whole-body heat treatment is carried out while you are lightly sedated.
With this sedation, you will be awake and be able to talk during the treatment, however you
will not be uncomfortable. This sedation is used to reduce any discomfort of the 6-hour
heat treatment procedure yet will allow you to speak to your nurses.

Your body temperature is raised to 104oF (40oC) over a period of 60-120 minutes. When the
body first reaches the target 104oF, we administer the gemcitabine chemotherapy over 60
minutes and continue to maintain the 104 oF body temperature for six hours. At the
conclusion of the six hours of thermal treatment, you will be cooled to your normal body
temperature, which takes about 30-45 minutes. The entire treatment lasts approximately 8
hours. After the treatment is completed, we will observe you for 2 to 12 hours to make sure
you have tolerated the treatment without a problem.

You will continue the low-dose Interferon-alpha. Additionally, you will be given 5-10 days
of Leukine (sargramostim) cytokine injections usually beginning 3-5 days after receiving
chemotherapy to help support the immune system by helping the body create more white blood
cells. White blood cells are important to help your body fight infection.

After treatment, you will need a complete blood count with platelet and differential count
each week. These lab studies can be done at your own doctor's office or hospital as long as
you make sure that the results are faxed to us. They can also be done in our clinic. We
will see you again in approximately three to four weeks and the treatment cycle will be
repeated.

We always attempt to perform at least two thermo-chemotherapy cycles. After the second
treatment, CT and/or MRI scans are repeated to see if your cancer is smaller. These scans,
along with a physical examination and the lab studies, are used to determine if additional
heat treatments will be performed. Additional treatments continue based on how well you
respond to the treatment. We limit to the number of heat treatments a patient may have
using these chemotherapy drugs to a total of six treatments.