A Phase II Trial of Gemcitabine, 5-Fluorouracil and Radiation Therapy in Locally Advanced Non-Metastatic Pancreatic Adenocarcinoma

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed pancreatic adenocarcinoma

- Non-metastatic disease that is unresectable due to any of the following:

- Tumor greater than 5 cm

- Bulky lymph nodes greater than 2 cm, but within the radiation port

- Vascular involvement or impingement of major vessels

- Involvement of colon, adrenal glands, or kidney

- Measurable or evaluable disease

- No prior therapy for pancreatic adenocarcinoma

- No peritoneal seeding or other evidence of metastatic disease by laparotomy or
laparoscopy

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- CTC 0-2

Life expectancy:

- Not specified

Hematopoietic:

- WBC at least 3,000/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 2.0 mg/dL

- AST no greater than 3 times upper limit of normal

Renal:

- Creatinine no greater than 2.0 mg/dL

Cardiovascular:

- No myocardial infarction within the past 6 months

Other:

- No other uncontrolled serious medical or psychiatric illness that would preclude
study compliance

- No other malignancy within the past 5 years except limited or curatively treated
basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- See Disease Characteristics

Chemotherapy:

- See Disease Characteristics

Endocrine therapy:

- See Disease Characteristics

Radiotherapy:

- No prior abdominal radiotherapy

Surgery:

- At least 2 weeks since prior major surgery