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Celecoxib, Irinotecan and Concurrent Radiotherapy in Preoperative Pancreatic Cancer

Primary Purpose

Pancreatic Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
celecoxib
irinotecan
concurrent radiotherapy
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Locally advanced pancreatic cancer, invasion of major arteries and veins around pancreas, No prior radiation or chemo

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UPMC Hillman Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Celecoxib, Irinotecan and Concurrent Radiotherapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Tumor diminishment for safe excision

Full Information

First Posted
September 13, 2005
Last Updated
July 1, 2010
Sponsor
University of Pittsburgh
Collaborators
Pharmacia and Upjohn
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1. Study Identification

Unique Protocol Identification Number
NCT00177853
Brief Title
Celecoxib, Irinotecan and Concurrent Radiotherapy in Preoperative Pancreatic Cancer
Official Title
A Phase I Study of Celecoxib, Irinotecan and Concurrent Radiotherapy in the Preoperative Treatment of Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Terminated
Why Stopped
terminated
Study Start Date
December 2006 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Pittsburgh
Collaborators
Pharmacia and Upjohn

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Locally advanced pancreatic cancer, invasion of major arteries and veins around pancreas, No prior radiation or chemo

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Celecoxib, Irinotecan and Concurrent Radiotherapy
Intervention Type
Drug
Intervention Name(s)
celecoxib
Other Intervention Name(s)
Celebrex
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
irinotecan
Other Intervention Name(s)
Camptosar
Intervention Description
Preoperative chemoradiation will consist of escalating doses of irinotecan (30 50 mg/m2 IV) once weekly for a total of 4 doses.
Intervention Type
Procedure
Intervention Name(s)
concurrent radiotherapy
Intervention Description
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 Measure Information:
Title
Determine efficacy of combination of irinotecan, celecoxib and concurrent radiotherapy on pancreatic cancer; determine highest/safest doses of these drugs
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Tumor diminishment for safe excision
Time Frame
75 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A. J. Moser, MD
Organizational Affiliation
University of Pittsburgh Medical Center Department of Surgery, Division of Surgical Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States

12. IPD Sharing Statement

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Celecoxib, Irinotecan and Concurrent Radiotherapy in Preoperative Pancreatic Cancer

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