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Gemcitabine, Cisplatin, and Celecoxib Treatment of Metastatic Pancreatic Cancer

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gemcitabine
Cisplatin
Celecoxib
Sponsored by
University of Michigan Rogel Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer

Eligibility Criteria

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

Inclusion Criteria Patients must have histologic or cytologic diagnosis of pancreatic adenocarcinoma. Patients must have clinical/radiologic evidence of metastatic disease (stage IV). Patients must not have received prior chemotherapy for metastatic disease. Prior adjuvant chemotherapy is allowed, provided that the last day of therapy was at least 6 months prior to starting treatment. Patients must have performance status of 0-2 on the SWOG scale. Patients must have an estimated life expectancy of at least 12 weeks. Patients must have adequate bone marrow function: absolute neutrophil count >1,500/cmm, platelet count >100,000/cmm. Patients must be informed of the investigational nature of this study and must give written informed consent prior to the receiving of treatment per this protocol. Patients must practice effective birth control while receiving treatment. Exclusion Criteria Patients with endocrine tumors or lymphoma of the pancreas. Patients with locally advanced pancreatic cancer. Patients with a proven history (radiographic and/or endoscopic) of peptic ulcer or esophageal erosions within one year of enrollment onto the study. Patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other non-steroidal anti-inflammatory drugs. History of active central nervous system (CNS) metastases. Inadequate liver function (bilirubin >3.0 mg/dL); transaminases (AST/ALT) >3 times upper limit of institutional normal. Inadequate renal function (creatinine >1.5 mg/dL). Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator). History of other malignancy, except for cancers that have been treated with a curative intent and patient is without evidence of active disease. Unresolved bacterial infection requiring treatment with antibiotics. Pregnant or lactating women may not participate in the study. Patients who have allergy to any of the study drugs or sulfa drugs. Patients infected with HIV-1 virus because of the undetermined effect of this chemotherapy regimen in patients with HIV-1 and the potential for serious interaction with anti-HIV medications.

Sites / Locations

  • University of Michigan

Outcomes

Primary Outcome Measures

To determine the overall survival time in patients with metastatic pancreatic cancer treated with the combination of gemcitabine, cisplatin and celecoxib.

Secondary Outcome Measures

To obtain data on overall time to disease progression
To determine time to treatment failure
To determine the tolerability of celecoxib with gemcitabine and cisplatin.
To characterize the nature of the toxicity for this combination in this patient group.
To determine objective tumor response
To determine the influence of therapy on the blood levels of prostaglandins and angiogenesis

Full Information

First Posted
September 9, 2005
Last Updated
April 29, 2008
Sponsor
University of Michigan Rogel Cancer Center
Collaborators
Eli Lilly and Company, Barbara Ann Karmanos Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00176813
Brief Title
Gemcitabine, Cisplatin, and Celecoxib Treatment of Metastatic Pancreatic Cancer
Official Title
Phase II Study of Gemcitabine, Cisplatin, and Celecoxib in the Treatment of Metastatic Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
November 2003 (Actual)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Michigan Rogel Cancer Center
Collaborators
Eli Lilly and Company, Barbara Ann Karmanos Cancer Institute

4. Oversight

5. Study Description

Brief Summary
This study will examine an investigational (experimental) treatment using gemcitabine, cisplatin, and celecoxib. Preliminary studies have shown that this experimental treatment may be effective in reducing the size of cancerous tumors and/or preventing further tumor growth. This is a phase II clinical trial studying the reactions of the patient's body and their tumor to the combination of gemcitabine, cisplatin, and celecoxib. The purpose of this study is to see if the tumor responds to this treatment and to determine how long the response lasts. This study will also look at what kind of side effects this experimental treatment causes and see how often these side effects occur. Blood levels of celecoxib will be measured to find out how this treatment affects factors (proteins) involved in new blood vessel formation and tumor growth (angiogenesis).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Primary Outcome Measure Information:
Title
To determine the overall survival time in patients with metastatic pancreatic cancer treated with the combination of gemcitabine, cisplatin and celecoxib.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
To obtain data on overall time to disease progression
Time Frame
12 months
Title
To determine time to treatment failure
Time Frame
12 months
Title
To determine the tolerability of celecoxib with gemcitabine and cisplatin.
Time Frame
12 months
Title
To characterize the nature of the toxicity for this combination in this patient group.
Time Frame
12 months
Title
To determine objective tumor response
Time Frame
12 months
Title
To determine the influence of therapy on the blood levels of prostaglandins and angiogenesis
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Patients must have histologic or cytologic diagnosis of pancreatic adenocarcinoma. Patients must have clinical/radiologic evidence of metastatic disease (stage IV). Patients must not have received prior chemotherapy for metastatic disease. Prior adjuvant chemotherapy is allowed, provided that the last day of therapy was at least 6 months prior to starting treatment. Patients must have performance status of 0-2 on the SWOG scale. Patients must have an estimated life expectancy of at least 12 weeks. Patients must have adequate bone marrow function: absolute neutrophil count >1,500/cmm, platelet count >100,000/cmm. Patients must be informed of the investigational nature of this study and must give written informed consent prior to the receiving of treatment per this protocol. Patients must practice effective birth control while receiving treatment. Exclusion Criteria Patients with endocrine tumors or lymphoma of the pancreas. Patients with locally advanced pancreatic cancer. Patients with a proven history (radiographic and/or endoscopic) of peptic ulcer or esophageal erosions within one year of enrollment onto the study. Patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other non-steroidal anti-inflammatory drugs. History of active central nervous system (CNS) metastases. Inadequate liver function (bilirubin >3.0 mg/dL); transaminases (AST/ALT) >3 times upper limit of institutional normal. Inadequate renal function (creatinine >1.5 mg/dL). Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator). History of other malignancy, except for cancers that have been treated with a curative intent and patient is without evidence of active disease. Unresolved bacterial infection requiring treatment with antibiotics. Pregnant or lactating women may not participate in the study. Patients who have allergy to any of the study drugs or sulfa drugs. Patients infected with HIV-1 virus because of the undetermined effect of this chemotherapy regimen in patients with HIV-1 and the potential for serious interaction with anti-HIV medications.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Zalupski, M.D.
Organizational Affiliation
University of Michigan Rogel Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

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Gemcitabine, Cisplatin, and Celecoxib Treatment of Metastatic Pancreatic Cancer

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