Gemcitabine, Herceptin and Radiation to Treat Cancer of the Pancreas
Status:
Completed
Trial end date:
2000-12-01
Target enrollment:
Participant gender:
Summary
This study will examine the safety and effectiveness of the drugs Gemcitabine and Herceptin,
given in conjunction with radiation therapy, for treating patients with cancer of the
pancreas. Gemcitabine is standard therapy for advanced pancreatic cancer. It damages tumor
cells and may enhance the effects of radiation therapy. Herceptin is a genetically engineered
antibody that has prevented some tumors from growing in patients with breast cancer. Because
breast and pancreatic cancer cells share an characteristic related to how Herceptin works
(similar HER-2/neu receptor proteins), it is thought that this drug may also inhibit growth
of tumors of the pancreas.
Patients with pancreatic cancer may be eligible for this study. Candidates will be screened
with a physical examination, chest X-ray, blood tests, electrocardiogram, and computerized
tomography (CT) scan of the chest, abdomen and pelvis. They will also have a minor surgical
procedure called a laparoscopy to evaluate the extent of their cancer. This procedure, done
under general anesthesia, requires an overnight hospital stay. A small incision (about 1
inch) is made in the abdomen and a thin, flexible tube with a light and special fibers at the
end is inserted into the opening. This device, called a laparoscope, allows the surgeon to
see inside the abdominal cavity to evaluate the tumor and also to remove a small piece of
tumor tissue for examination.
Patients accepted into the study will be assigned to one of two treatment groups, according
to whether or not their tumor can be removed with surgery. Patients will be asked to complete
a Quality of Life Evaluation before treatment begins and again at each follow-up visit. This
15-minute questionnaire assesses patients' feelings, their ability to carry out usual
activities, and the effects of therapy on their general health and well being.
Patients in both treatment groups will be given the same chemotherapy, on an outpatient basis
unless special circumstances require hospitalization. Gemcitabine is infused over 30 to 60
minutes through an intravenous catheter (IV)-a thin plastic tube inserted into an arm vein.
Herceptin is then given over 30 to 90 minutes through the same IV line. Radiation therapy to
the abdomen will start the same day, after the drugs have been administered, and will
continue for the next 4 days. This treatment cycle-chemotherapy plus 5 days of radiation
therapy-will be repeated each week for 6 weeks.
Within 6 weeks after the last treatment, the patient's tumor will be evaluated with a blood
test and CT scan of the chest, abdomen and pelvis to determine if it can be removed with
surgery. If so, the procedure will be done under general anesthesia and will require a 7- to
10-day hospital stay. If the tumor cannot be removed with surgery, another biopsy will be
taken to evaluate the tumor's response to the chemotherapy and radiation treatment.
All patients will receive additional chemotherapy beginning 6 weeks after surgery (for
patients whose tumors were removed) or 6 weeks after radiation therapy (for patients whose
tumors could not be removed). Gemcitabine and Herceptin will be given IV once a week for 3
weeks followed by a week of rest. This 4-week treatment cycle will be repeated up to six
times.
After treatment ends, patients will be evaluated with CT scans or X-rays and blood tests
every 3 to 4 months for the first 2 years and every 6 months thereafter to evaluate disease
status.