Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
National Institutes of Health Clinical Center (CC)
OBJECTIVES: I. Determine radiographic and/or pathologic response, time to disease progression, and survival in patients with advanced adenocarcinoma of the pancreas treated with neoadjuvant intraperitoneal gemcitabine and intravenous gemcitabine with radiotherapy followed by surgery and adjuvant intraperitoneal gemcitabine, intravenous gemcitabine, and fluorouracil. II. Determine the pharmacokinetics of intraperitoneal gemcitabine in these patients. III. Correlate patterns of mRNA expression with response to this regimen and prognosis in these patients. PROTOCOL OUTLINE: Patients receive gemcitabine intraperitoneally (IP) every 6 hours for 4 doses on day 1. Treatment repeats in 1 week for a total of 2 courses. Beginning 1-3 weeks after completion of IP chemotherapy, patients receive gemcitabine IV over 30-60 minutes on day 1 or 2 of each week and radiotherapy on days 1-5 of each week for 6 weeks. Within 6 weeks after the completion of combination chemotherapy and radiotherapy, patients with stable or responding disease undergo surgical resection. Patients with completely resected extrapancreatic disease then receive 2 additional courses of IP gemcitabine beginning 1-3 weeks after surgery. Beginning 3 weeks after the completion of IP chemotherapy, patients receive gemcitabine IV once weekly for a total of 3 weeks and fluorouracil IV continuously for up to 6 months. Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 10-100 patients will be accrued for this study within 2 years.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
