Celecoxib, Irinotecan and Concurrent Radiotherapy in Preoperative Pancreatic Cancer - Full Text View

Sponsors and Collaborators:	University of Pittsburgh Pharmacia and Upjohn
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00177853

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 I

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Irinotecan Irinotecan hydrochloride Celecoxib 4-(5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide Pancrelipase Ultrase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase I Study of Celecoxib, Irinotecan and Concurrent Radiotherapy in the Preoperative Treatment of Pancreatic Cancer

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:	March 2003
Estimated Study Completion Date:	December 2008
Primary Completion Date:	July 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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. Drug: irinotecan Preoperative chemoradiation will consist of escalating doses of irinotecan (30 50 mg/m2 IV) once weekly for a total of 4 doses. 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.

Arms

Assigned Interventions

1: Experimental

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.

Drug: irinotecan

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

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

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

Responsible Party:	UPCI ( A. James Moser, MD )
Study ID Numbers:	02-128
Study First Received:	September 13, 2005
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00177853
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

Study placed in the following topic categories:

Celecoxib
Digestive System Diseases
Digestive System Neoplasms
Pancreatic Neoplasms
Irinotecan
Endocrine System Diseases

Pancreatic Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Pancrelipase
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009