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Celecoxib, Irinotecan and Concurrent Radiotherapy in Preoperative 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: 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

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 15, 2005
Last Update Posted Date July 2, 2010
Study Start Date  ICMJE December 2006
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2008)		 Determine efficacy of combination of irinotecan, celecoxib and concurrent radiotherapy on pancreatic cancer; determine highest/safest doses of these drugs [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)		 Determine efficacy of combination irinotecan,celecoxib and concurrent radiotherapy on pancreatic cancer; determine highest/safest doses of these drugs
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2008)		 Tumor diminishment for safe excision [ Time Frame: 75 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)		 tumor diminishment for safe excision
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Celecoxib, Irinotecan and Concurrent Radiotherapy in Preoperative Pancreatic Cancer
Official Title  ICMJE A Phase I Study of Celecoxib, Irinotecan and Concurrent Radiotherapy in the Preoperative Treatment of Pancreatic Cancer
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Experimental: 1
Celecoxib, Irinotecan and Concurrent Radiotherapy
Interventions:
  • Drug: celecoxib
  • Drug: irinotecan
  • Procedure: concurrent radiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: December 13, 2006)		 23
Original Enrollment  ICMJE
 (submitted: September 13, 2005)		 20
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00177853
Other Study ID Numbers  ICMJE 02-128
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party A. James Moser, MD, UPCI
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE University of Pittsburgh
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Pharmacia and Upjohn
Investigators  ICMJE
Principal Investigator: A. J. Moser, MD University of Pittsburgh Medical Center Department of Surgery, Division of Surgical Oncology
PRS Account University of Pittsburgh
Verification Date July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP