Celecoxib, Irinotecan and Concurrent Radiotherapy in Preoperative Pancreatic Cancer
NCT ID: NCT00177853
Last Updated: 2010-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
23 participants
INTERVENTIONAL
2006-12-31
2010-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Celecoxib, Irinotecan and Concurrent Radiotherapy
celecoxib
Patients will start celecoxib (200mg PO BID) beginning 3-5 days prior to chemoradiation at home and receive the drug until 30 days following the completion of chemoradiation.
irinotecan
Preoperative chemoradiation will consist of escalating doses of irinotecan (30 50 mg/m2 IV) once weekly for a total of 4 doses.
concurrent radiotherapy
50.4 cGy of standard external beam radiation. The radiation will be given in 28 treatments of 1.8 cGy per treatment over 5.5 weeks. This will be given in an outpatient setting.
Interventions
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celecoxib
Patients will start celecoxib (200mg PO BID) beginning 3-5 days prior to chemoradiation at home and receive the drug until 30 days following the completion of chemoradiation.
irinotecan
Preoperative chemoradiation will consist of escalating doses of irinotecan (30 50 mg/m2 IV) once weekly for a total of 4 doses.
concurrent radiotherapy
50.4 cGy of standard external beam radiation. The radiation will be given in 28 treatments of 1.8 cGy per treatment over 5.5 weeks. This will be given in an outpatient setting.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Arterial invasion or encasement
* Invasion/encasement of the portomesenteric veins
* Patients who have been previously denied operation
* Obstructive jaundice must be drained with a polyethylene biliary stent or surgical bypass prior to beginning treatment.
* White blood cell count \> 3500 per ml and platelet count \> 100,000 per ml
* Serum creatinine ≤ 1.5 mg/dl
* Bilirubin ≤ 1.5
* ECOG performance status \< 2
Exclusion Criteria
* Evidence of distant metastasis or malignant lymphadenopathy
* Concurrent malignancies
* History of allergic reactions to celecoxib or to sulfa drugs
* No non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, magnesium or aluminum containing antacids, fluconazole or lithium may be administered within 5 days of study entry, during the study and for the 30 days following the completion of all study treatments.
* Pregnant women and lactating women
* Uncontrolled or serious intercurrent illness
* HIV-positive patients receiving combination antiretroviral therapy
18 Years
ALL
No
Sponsors
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Pharmacia and Upjohn
INDUSTRY
University of Pittsburgh
OTHER
Responsible Party
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UPCI
Principal Investigators
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A. J. Moser, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh Medical Center Department of Surgery, Division of Surgical Oncology
Locations
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UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Countries
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Other Identifiers
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02-128
Identifier Type: -
Identifier Source: org_study_id
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