combination chemotherapy and radiation therapy in treating patients with pancreatic cancer

Conditions: Pancreatic Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. radiation therapy uses high-energy x-rays to damage tumor cells. combining chemotherapy with radiation therapy may kill more tumor cells. purpose: phase ii trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients who have locally advanced pancreatic cancer.

objectives: * determine the overall survival of patients with locally advanced non-metastatic pancreatic adenocarcinoma treated with gemcitabine, fluorouracil, and radiotherapy. * determine the time to progression in patients treated with this regimen. * determine the overall clinical response in patients treated with this regimen. * determine the toxicity of this regimen in these patients. outline: this is a multicenter study. patients receive gemcitabine iv over 30 minutes once weekly and fluorouracil iv continuously on days 1-5 weekly for 6 weeks. patients concurrently undergo radiotherapy 5 days a week for 6 weeks. three weeks after the completion of chemoradiotherapy, patients receive gemcitabine iv over 30 minutes once weekly on weeks 1-3. treatment repeats every 4 weeks for a total of 4 courses in the absence of disease progression or unacceptable toxicity. patients are followed every 2 months for 1 year and then every 3 months for 2 years. projected accrual: a total of 78 patients will be accrued for this study within 24 months.

Eligibility 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

Keywords: stage ii pancreatic cancer stage iii pancreatic cancer adenocarcinoma of the pancreas