A Phase I Study of Gemcitabine, 5-Fluorouracil, and Radiation Therapy in the Treatment of Locally Unresectable Non-Metastatic Pancreatic Cancer
- Ultimately we plan to find the maximum tolerated dose of the combination of
gemcitabine, 5-fluorouracil and radiation therapy. We also hope to assess the number
of people who respond to this therapy and to assess the feasibility of giving
intraoperative radiation therapy following gemcitabine, 5-fluorouracil, and external
beam radiation therapy.
- A surgical procedure, either laparotomy or laparoscopy, will be required to check the
amount of disease before treatment is started.
- All patients will receive the same two chemotherapy drugs and radiation therapy. Both
gemcitabine and 5-fluorouracil will begin on the first week of radiation therapy.
5-fluorouracil will be given continuously by intravenous infusion and will continue
until the external beam radiation therapy is completed. The gemcitabine will be given
(at different doses for each cohort of patients) once per week for seven weeks.
Radiation therapy will be given daily for five days for seven weeks. On those days
when gemcitabine is given, radiation therapy will be given approximately four hours
after the gemcitabine dose.
- Four weeks after completing the radiation therapy and chemotherapy, patients will
undergo a scan to check the extent of disease. Following the scan, patients will be
considered for a repeat surgical procedure to remove the tumor, if possible. If
removal of the tumor is not possible, patients will receive intraoperative radiation
- After completing the therapy, patients will be seen at least every 3 months for one
year. A complete physical exam and CT scan will be done regularly.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the maximum tolerated dose of weekly gemcitabine when administered with continuous infusion 5-fluorouracil and external beam radiation.
Charles S. Fuchs, MD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|