Celecoxib, Irinotecan and Concurrent Radiotherapy in Preo... | NCT00177853

Studies
Celecoxib, Irinotecan and Concurrent Radiotherapy in Preoperative Pancreatic Cancer

NCT00177853

Sponsor

University of Pittsburgh

Status

Terminated

Last Update Posted

Jul 2, 2010Estimated

Enrollment

23Estimated

Phase

Phase 1

Conditions

Pancreatic Cancer

Interventions

celecoxib
irinotecan
concurrent radiotherapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

terminated

Expanded Access Info

Start Date

Dec 2006

Primary Completion Date

Dec 2006Actual

Completion Date

Jul 2010Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2010

Last Update Posted Date

Jul 2, 2010Estimated

Name	Class
Pharmacia and Upjohn	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

23Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Celecoxib, Irinotecan and Concurrent Radiotherapy	Drug: celecoxib Drug: irinotecan Procedure: concurrent radiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
celecoxib	Drug	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.

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
Tumor diminishment for safe excision		75 days

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
A. J. Moser, MD	University of Pittsburgh Medical Center Department of Surgery, Division of Surgical Oncology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UPMC Hillman Cancer Center		Pittsburgh	Pennsylvania	15232	United States

Condition Browse Module

MeSH Terms

ID	Term
D010190	Pancreatic Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068579	Celecoxib
D000077146	Irinotecan

Ancestor Terms

ID	Term
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided