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

History of Changes

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

July 1, 2010

Start Date ^ICMJE

December 2006

Primary Completion Date

December 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Determine efficacy of combination irinotecan,celecoxib and concurrent radiotherapy on pancreatic cancer; determine highest/safest doses of these drugs

Change History

Complete list of historical versions of study NCT00177853 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Tumor diminishment for safe excision

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Arm (s)

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

Completion Date

July 2010

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00177853

Other Study ID Numbers ^ICMJE

02-128

Has Data Monitoring Committee

Yes

Responsible Party

A. James Moser, MD, UPCI

Study Sponsor ^ICMJE

University of Pittsburgh

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

Information Provided By

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

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