Regional Chemotherapy in Locally Advanced Pancreatic Cancer: RECLAP Trial
Status:
Completed
Trial end date:
2014-07-23
Target enrollment:
Participant gender:
Summary
Background:
- Pancreatic cancer is difficult to treat because by the time most cases are diagnosed, the
tumors are too large to be removed surgically. Standard intravenous chemotherapy may shrink
some of the tumor, but even with chemotherapy only about 25 percent of patients will live for
1 year following diagnosis. Several preliminary studies have shown that it is safe to give
chemotherapy directly into the pancreas in the area of the tumor, and that giving gemcitabine
over a longer period increases the amount of drug that is available to the tumor. Researchers
are interested in studying whether giving the approved pancreatic cancer chemotherapy drug
gemcitabine directly into the pancreas in the area of the cancer and at a slow rate of
infusion is a safe and effective treatment.
Objectives:
- To test the safety and effectiveness of administering gemcitabine directly to a pancreatic
tumor at a slow rate of infusion.
Eligibility:
- Individuals at least 18 years of age who have been diagnosed with pancreatic cancer that is
currently too large to be removed surgically but has not yet spread to other organs.
Design:
- Participants will be screened with a full medical history and physical examination,
blood and urine tests, and imaging studies.
- Participants will undergo pancreatic angiography and embolization, during which a
catheter will be threaded into the blood vessels near the pancreas and a contrast dye
will be used to show the blood vessels supplying the tumor. These blood vessels will
then be surgically closed off.
- After the embolization, gemcitabine will be given as an infusion into the area around
the tumor over 24 hours.
- Participants will return to the clinical center every 2 weeks after the first infusion
for additional infusions of gemcitabine, using the same procedures as above.
Participants will be monitored with frequent blood tests and imaging studies.
- Two weeks after the fourth treatment (course 1), participants will have more imaging
studies, a physical examination, and blood tests. If the tumor is shrinking,
participants will have two more courses of treatment (eight more infusions of
gemcitabine).
- Participants will have followup visits every 3 months for 2 years following the last
treatment and then every 6 months.