Celecoxib, Irinotecan And Concurrent Radiotherapy In Preoperative Pancreatic Cancer

Study Overview

Celecoxib, Irinotecan and Concurrent Radiotherapy in Preoperative 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.

Pancreatic Cancer

DRUG: celecoxib
DRUG: irinotecan
PROCEDURE: concurrent radiotherapy

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Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2005-09-13	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2010-07-01
First Submitted that Met QC Criteria 2005-09-13	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2010-07-02
First Posted (ESTIMATED) 2005-09-15	Results First Posted N/A	Last Verified 2010-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/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. 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.

Participant Group/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.

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.

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

Secondary Outcome Measures	Measure Description	Time Frame
Tumor diminishment for safe excision		75 days

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Pharmacia and Upjohn

Investigators

PRINCIPAL_INVESTIGATOR: A. J. Moser, MD, University of Pittsburgh Medical Center Department of Surgery, Division of Surgical Oncology

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

Patients

Caregivers

Clinical Trial Record