Combination Chemotherapy, and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy work in 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. Giving combination chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be removed.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients who may undergo surgery for locally advanced pancreatic cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Nebraska
• Collaborator: National Cancer Institute (NCI)
• Treatments: Calcium; Fluorouracil; Gemcitabine; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of adenocarcinoma of the pancreas

• Locally advanced disease

• Potentially resectable disease

• No early stage resectable disease

• No evidence of distant metastases to the liver or peritoneal area according to imaging studies and laparoscopic staging

PATIENT CHARACTERISTICS:

Age

• 19 and over

Performance status

• Karnofsky 60-100%

Life expectancy

• Not specified

Hematopoietic

• Absolute granulocyte count ≥ 2,000/mm^3

• Platelet count ≥ 100,000/mm^3

Hepatic

• Bilirubin ≤ 2.0 mg/dL (in the absence of biliary obstruction)

• If biliary obstruction is present, patients must undergo biliary decompression

• Bilirubin ≤ 3.0 mg/dL after biliary drainage has been established

Renal

• Creatinine ≤ 1.6 mg/dL

Cardiovascular

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No serious uncontrolled cardiac arrhythmia

Other

• Not pregnant or nursing

• No uncontrolled illness

• No active or ongoing infection requiring IV antibiotics

• No marked intolerance to 5-fluoropyrimidines (i.e., fluorouracil, floxuridine, capecitabine, or fluorocytosine)

• No allergy to sulfonamides, aspirin, or non-steroidal anti-inflammatory drugs

• No allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with study chemotherapy

• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated noninvasive carcinoma

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy for pancreatic cancer

Endocrine therapy

• Not specified

Radiotherapy

• No prior abdominal radiotherapy

Surgery

• Not specified

Other

• No concurrent non-steroidal anti-inflammatory medication