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Celecoxib, Irinotecan and Concurrent Radiotherapy in Preoperative Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT00177853
Recruitment Status : Terminated (terminated)
First Posted : September 15, 2005
Last Update Posted : July 2, 2010
Sponsor:
Collaborator:
Pharmacia and Upjohn
Information provided by:
University of Pittsburgh

Study Description
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Brief Summary:
The purposes of this study are to examine the effects of a new combination of drugs, celecoxib (Celebrex®) and irinotecan (CPT-11), with standard radiation therapy on people before they undergo surgery; to determine what effects this combination has on pancreatic cancer; and to determine the highest dose of celecoxib and irinotecan that can be given safely without causing severe side effects. While not an endpoint, it is hoped that this combination will also shrink tumors enough for excision.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: celecoxib Drug: irinotecan Procedure: concurrent radiotherapy Phase 1

Detailed Description:
The purposes of this study are to examine the effects of a new combination of drugs, celecoxib (Celebrex®) and irinotecan (CPT-11), with standard radiation therapy on people before they undergo surgery; to determine what effects this combination has on pancreatic cancer; and to determine the highest dose of celecoxib and irinotecan that can be given safely without causing severe side effects. While not an endpoint, it is hoped that this combination will also shrink tumors enough for excision.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Celecoxib, Irinotecan and Concurrent Radiotherapy in the Preoperative Treatment of Pancreatic Cancer
Study Start Date : December 2006
Actual Primary Completion Date : December 2006
Actual Study Completion Date : July 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Celecoxib, Irinotecan and Concurrent Radiotherapy
 Drug: 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.
Other Name: Celebrex

Drug: irinotecan
Preoperative chemoradiation will consist of escalating doses of irinotecan (30 50 mg/m2 IV) once weekly for a total of 4 doses.
Other Name: Camptosar

Procedure: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Determine efficacy of combination of irinotecan, celecoxib and concurrent radiotherapy on pancreatic cancer; determine highest/safest doses of these drugs [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Tumor diminishment for safe excision [ Time Frame: 75 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Locally advanced carcinoma of the pancreas
  • 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:

  • Prior chemotherapy, radiotherapy, or investigational agents for pancreatic cancer
  • 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
Contacts and Locations
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Information from the National Library of Medicine

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): NCT00177853


Locations
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United States, Pennsylvania
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
University of Pittsburgh
Pharmacia and Upjohn
Investigators
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Principal Investigator: A. J. Moser, MD University of Pittsburgh Medical Center Department of Surgery, Division of Surgical Oncology
More Information
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Responsible Party: A. James Moser, MD, UPCI
ClinicalTrials.gov Identifier: NCT00177853    
Other Study ID Numbers: 02-128
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: July 2, 2010
Last Verified: July 2010
Keywords provided by University of Pittsburgh:
Locally advanced pancreatic cancer
invasion of major arteries and veins around pancreas
No prior radiation or chemo
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Celecoxib
Irinotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors