Combination Chemotherapy, and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer
Completed · Phase 2
Conditions studied: Pancreatic Cancer
In brief
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.
Key facts
- Study ID
- NCT00089024
- Run by
- University of Nebraska
- People needed
- 29
- Starts
- 2004-02-25
- Expected to finish
- 2014-12-01
- Last updated by the study team
- 2023-09-29
Who can join
Age: 19 and older, up to 120. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Eppley Cancer Center, University of Nebraska Medical Center — Omaha, Nebraska, United States
Full record on ClinicalTrials.gov
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