This trial is active, not recruiting.

Condition pancreatic cancer
Treatments fluorouracil, gemcitabine hydrochloride, leucovorin calcium, oxaliplatin, adjuvant therapy, conventional surgery, neoadjuvant therapy, radiation therapy
Phase phase 2
Sponsor University of Nebraska
Collaborator National Cancer Institute (NCI)
Start date February 2004
End date December 2013
Trial size 50 participants
Trial identifier NCT00089024, 035-04, P30CA036727, UNMC-03504


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Antitumor and clinical benefit response
time frame: After 6 weeks of chemotherapy and then after 4 weeks of chemo-radiation.
time frame: Weekly
Correlation of achieved steady-state plasma levels with clinical toxicity
time frame: during protracted venous infusion
Importance of polymorphic variations in genomic DNA of pertinent genes on response and toxicity
time frame: Prior to starting therapy
Gene expression profiles of primary and metastatic pancreatic tumors before and after treatment
time frame: Before and after treatment

Eligibility Criteria

Male or female participants at least 19 years old.

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

Additional Information

Official title A Phase II Study Of Neo-Adjuvant Chemotherapy And Radiation In Patients With Locally Advanced Pancreatic Cancer
Description OBJECTIVES: - Determine the antitumor and clinical benefit response to neoadjuvant chemoradiotherapy comprising gemcitabine, fluorouracil, leucovorin calcium, and oxaliplatin in patients with potentially resectable locally advanced adenocarcinoma of the pancreas. - Determine the toxic effects of this regimen in these patients. - Determine the achieved steady-state plasma levels of gemcitabine and fluorouracil in these patients and correlate these plasma levels with clinical toxicity associated with this regimen. - Determine the potential importance of polymorphic variations in genomic DNA of pertinent genes (whose protein products are targets of the antineoplastic drugs used in this study) on response to and toxicity of this regimen in these patients. - Determine the gene expression profiles of primary and metastatic pancreatic tumors before and after treatment with this regimen. OUTLINE: - Neoadjuvant chemotherapy: Patients receive gemcitabine IV over 30 minutes and fluorouracil IV continuously over 24 hours on days 2 and 9, and leucovorin calcium orally on days 1 and 8 and IV on days 2 and 9. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. - Neoadjuvant chemoradiotherapy: Beginning on day 42, patients undergo chemoradiotherapy comprising oxaliplatin IV over 2 hours on days 42, 49, 56, 63, 70, and 77 and fluorouracil IV continuously on days 42-78 with external beam radiotherapy. - Surgery: Patients undergo surgical resection 42-56 days after completion of chemoradiotherapy. - Adjuvant chemotherapy: After post-operative recovery, patients receive 2 additional courses of gemcitabine, fluorouracil, and leucovorin calcium. If surgical resection is not possible, patients with stable or responsive disease resume gemcitabine, fluorouracil, and leucovorin calcium indefinitely in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Trial information was received from ClinicalTrials.gov and was last updated in June 2010.
Information provided to ClinicalTrials.gov by University of Nebraska.