Status:
COMPLETED
Combination Chemotherapy, and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer
Lead Sponsor:
University of Nebraska
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
19-120 years
Phase:
PHASE2
Brief 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 comb...
Detailed Description
OBJECTIVES: * Determine the antitumor and clinical benefit response to neoadjuvant chemoradiotherapy comprising gemcitabine, fluorouracil, leucovorin calcium, and oxaliplatin in patients with potenti...
Eligibility Criteria
Inclusion
- Diagnosis of adenocarcinoma of the pancreas
- o Locally advanced disease
- Potentially resectable disease
- 19 years of age and over
- Karnofsky 60-100%
- Absolute granulocyte count ≥ 2,000/mm\^3
- Platelet count ≥ 100,000/mm\^3
- 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
- Creatinine ≤ 1.6 mg/dL
Exclusion
- No early stage resectable disease
- No concurrent non-steroidal anti-inflammatory medication
- No evidence of distant metastases to the liver or peritoneal area according to imaging studies and laparoscopic staging
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No serious uncontrolled cardiac arrhythmia
- 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
- No prior chemotherapy for pancreatic cancer
- No prior abdominal radiotherapy
Key Trial Info
Start Date :
February 25 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00089024
Start Date
February 25 2004
End Date
December 1 2014
Last Update
September 29 2023
Active Locations (1)
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1
Eppley Cancer Center, University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-6805