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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
  Purpose

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 Intervention Phase
Pancreatic Cancer
Drug: celecoxib
Drug: irinotecan
Procedure: concurrent radiotherapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Celecoxib, Irinotecan and Concurrent Radiotherapy in the Preoperative Treatment of Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Tumor diminishment for safe excision [ Time Frame: 75 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 23
Study Start Date: December 2006
Study Completion Date: July 2010
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00177853

Locations
United States, Pennsylvania
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
University of Pittsburgh
Pharmacia and Upjohn
Investigators
Principal Investigator: A. J. Moser, MD University of Pittsburgh Medical Center Department of Surgery, Division of Surgical Oncology
  More Information

No publications provided

Responsible Party: A. James Moser, MD, UPCI
ClinicalTrials.gov Identifier: NCT00177853     History of Changes
Other Study ID Numbers: 02-128
Study First Received: September 13, 2005
Last Updated: July 1, 2010
Health Authority: United States: Institutional Review Board

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:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases
Celecoxib
Irinotecan
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Sensory System Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 25, 2014