Gemcitabine, 5-Fluorouracil, and Radiation Therapy in the Treatment of Non-Metastatic Pancreatic Cancer
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer, Pancreatic Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 72 |
| Updated: | 12/21/2016 |
| Start Date: | January 1998 |
| End Date: | August 2008 |
A Phase I Study of Gemcitabine, 5-Fluorouracil, and Radiation Therapy in the Treatment of Locally Unresectable Non-Metastatic Pancreatic Cancer
The purpose of this study is to test a new treatment of pancreatic cancer that cannot be
removed by surgery. This treatment is a Phase I dose escalation research study which will
combine one drug at increasing doses with a fixed dose of a second drug and radiation
therapy. The drug that will be used at increasing doses is gemcitabine whereas
5-fluorouracil will remain the same for all patients.
removed by surgery. This treatment is a Phase I dose escalation research study which will
combine one drug at increasing doses with a fixed dose of a second drug and radiation
therapy. The drug that will be used at increasing doses is gemcitabine whereas
5-fluorouracil will remain the same for all patients.
- 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 therapy.
- 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.
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 therapy.
- 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.
Inclusion Criteria:
- Histologic confirmation of locally unresectable pancreatic adenocarcinoma. Patients
with either measurable of evaluable disease are eligible.
- Unresectable, non-metastatic tumors. Unresectable patients include those with local
extension of the tumor into adjacent structures and/or nodal metastasis.
- Total bilirubin < 2.0 mg/dl
- AST < 3x ULN
- Serum creatinine < 2.0 mg/dl
- WBC > 3,000/mm3
- Platelets > 100,000/mm3
- ECOG performance status < or = to 2
- Life expectancy of greater than 12 weeks
Exclusion Criteria:
- Evidence of peritoneal seeding by malignancy
- Prior radiation therapy or chemotherapy for pancreatic cancer
- Myocardial infarction in the past 6 months
- Major surgery in past two weeks
- Uncontrolled serious medical or psychiatric illness
- Pregnant or lactating women
- Concurrent malignancy of any site, except limited basal cell carcinoma or squamous
cell carcinoma of the skin or carcinoma in situ of the cervix.
We found this trial at
3
sites
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
Click here to add this to my saved trials
Click here to add this to my saved trials
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
Click here to add this to my saved trials