Pancreatic Cancer Clinical Trial
Official title:
Pilot Study of Gemcitabine and IORT/EBRT in Locally Advanced Upper Gastrointestinal Malignancies
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop
the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy together
with radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of gemcitabine when
given together with radiation therapy in treating patients with locally advanced upper
gastrointestinal cancer.
OBJECTIVES:
- To determine the feasibility of combining preoperative or intraoperative gemcitabine
hydrochloride with intraoperative radiotherapy.
- To determine the tolerance of gemcitabine hydrochloride given concurrently with
external-beam radiotherapy.
- To measure biochemical parameters in tumors that may correlate with the effectiveness
of therapy.
OUTLINE: Patients receive gemcitabine hydrochloride IV 12-18 hours prior to planned surgery.
All patients then undergo an exploratory laparotomy that may include tumor debulking,
Whipple-type resection (pancreaticoduodenectomy), total pancreatectomy, gastrojejunostomy,
total or partial gastrectomy, or cholecystectomy and en bloc resection depending on the
extent of the disease. Patients with no metastatic disease beyond regional lymph nodes also
undergo intraoperative radiotherapy.
Beginning 2-6 weeks after surgery, patients undergo external-beam radiotherapy (EBRT) once a
day 5 days a week for up to 7 weeks. Patients also receive escalating doses of gemcitabine
hydrochloride IV at the beginning of each week of EBRT.
Patients undergo tissue sample collection periodically for correlative studies. Samples are
analyzed for thymidylate synthase (TS), ribonucleotide reductase (RR),
excision-repair-cross-complementing (ERCC)-1 protein, deoxycytidine kinase mRNA. Biopsy
tissues are also analyzed for gemcitabine triphosphate, dATP, and dCTP content. p53 status
is assessed via immunohistochemistry and mRNA levels via quantitative polymerase chain
reaction (PCR).
After completion of study treatment, patients are followed every 3 months for 2 years, every
6 months for 2 years, and then once a year thereafter.
;
Primary Purpose: Treatment
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