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Celecoxib, Irinotecan and Concurrent Radiotherapy in Preoperative Pancreatic Cancer

This study has been terminated.
(terminated)
Sponsor:
Collaborator:
Pharmacia and Upjohn
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00177853
First received: September 13, 2005
Last updated: July 1, 2010
Last verified: July 2010

September 13, 2005
July 1, 2010
December 2006
December 2006   (final data collection date for primary outcome measure)
Determine efficacy of combination of irinotecan, celecoxib and concurrent radiotherapy on pancreatic cancer; determine highest/safest doses of these drugs [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Determine efficacy of combination irinotecan,celecoxib and concurrent radiotherapy on pancreatic cancer; determine highest/safest doses of these drugs
Complete list of historical versions of study NCT00177853 on ClinicalTrials.gov Archive Site
Tumor diminishment for safe excision [ Time Frame: 75 days ] [ Designated as safety issue: No ]
Tumor diminishment for safe excision
Not Provided
Not Provided
 
Celecoxib, Irinotecan and Concurrent Radiotherapy in Preoperative Pancreatic Cancer
A Phase I Study of Celecoxib, Irinotecan and Concurrent Radiotherapy in the Preoperative Treatment of Pancreatic Cancer

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Cancer
  • 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.
Experimental: 1
Celecoxib, Irinotecan and Concurrent Radiotherapy
Interventions:
  • Drug: celecoxib
  • Drug: irinotecan
  • Procedure: concurrent radiotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
23
July 2010
December 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00177853
02-128
Yes
A. James Moser, MD, UPCI
University of Pittsburgh
Pharmacia and Upjohn
Principal Investigator: A. J. Moser, MD University of Pittsburgh Medical Center Department of Surgery, Division of Surgical Oncology
University of Pittsburgh
July 2010

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