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A Phase I Study of Gemcitabine, 5-Fluorouracil, and Radiation Therapy in the Treatment of Locally Unresectable Non-Metastatic Pancreatic Cancer

Phase 1
18 Years
72 Years
Open (Enrolling)
Pancreatic Cancer

Thank you

Trial Information

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.

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the maximum tolerated dose of weekly gemcitabine when administered with continuous infusion 5-fluorouracil and external beam radiation.

Outcome Time Frame:

phase 1

Safety Issue:


Principal Investigator

Charles S. Fuchs, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

January 1998

Completion Date:

October 2012

Related Keywords:

  • Pancreatic Cancer
  • gemcitabine
  • 5-fluorouracil
  • 5-FU
  • unresectable pancreatic cancer
  • non-metastatic pancreatic cancer
  • Pancreatic Neoplasms



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Brigham and Women's Hospital Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617