Combination Chemotherapy, and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00089024 |
Recruitment Status
: Unknown
Verified June 2010 by University of Nebraska.
Recruitment status was: Active, not recruiting
First Posted
: August 5, 2004
Last Update Posted
: June 3, 2010
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pancreatic Cancer | Drug: fluorouracil Drug: gemcitabine hydrochloride Drug: leucovorin calcium Drug: oxaliplatin Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Study Of Neo-Adjuvant Chemotherapy And Radiation In Patients With Locally Advanced Pancreatic Cancer |
Study Start Date : | February 2004 |
Estimated Primary Completion Date : | December 2013 |

-
Drug: fluorouracil
Patients who have undergone surgical resection, after post-operative recovery, will receive two additional cycles of gemcitabine/5-FU/leucovorin. Patients will then be followed at 3 month intervals with a history and physical exam, CT scan of the chest/abdomen/pelvis, and tumor markers.
If surgical resection is not possible, patients with stable or responsive disease will resume gemcitabine/5-FU/leucovorin and continue on it indefinitely until disease progression provided the patient tolerates it and wishes to remain on therapy.
- Antitumor and clinical benefit response [ Time Frame: After 6 weeks of chemotherapy and then after 4 weeks of chemo-radiation. ]
- Toxicity [ Time Frame: Weekly ]
- Correlation of achieved steady-state plasma levels with clinical toxicity [ Time Frame: during protracted venous infusion ]Correlative
- Importance of polymorphic variations in genomic DNA of pertinent genes on response and toxicity [ Time Frame: Prior to starting therapy ]Correlative
- Gene expression profiles of primary and metastatic pancreatic tumors before and after treatment [ Time Frame: Before and after treatment ]Correlative

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 19 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00089024
United States, Nebraska | |
UNMC Eppley Cancer Center at the University of Nebraska Medical Center | |
Omaha, Nebraska, United States, 68198-6805 |
Study Chair: | Jean L. Grem, MD | University of Nebraska |
Responsible Party: | Jean L. Grem, UNMC Eppley Cancer Center at the University of Nebraska Medical Center |
ClinicalTrials.gov Identifier: | NCT00089024 History of Changes |
Other Study ID Numbers: |
035-04 P30CA036727 ( U.S. NIH Grant/Contract ) UNMC-03504 |
First Posted: | August 5, 2004 Key Record Dates |
Last Update Posted: | June 3, 2010 |
Last Verified: | June 2010 |
Keywords provided by University of Nebraska:
adenocarcinoma of the pancreas stage II pancreatic cancer stage III pancreatic cancer |
Additional relevant MeSH terms:
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine Fluorouracil Oxaliplatin Levoleucovorin |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antidotes Protective Agents |