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Gemcitabine and Celecoxib in Treating Patients With Metastatic Pancreatic Cancer

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Celecoxib
Gemcitabine Hydrochloride
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring recurrent pancreatic cancer, stage IV pancreatic cancer

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic pancreatic cancer Radiographic evidence of disease No known brain metastases PATIENT CHARACTERISTICS: Age Any age Performance status ECOG 0-2 OR Karnofsky 60-100% Life expectancy Not specified Hematopoietic WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST/ALT no greater than 2.5 times ULN Renal Creatinine normal OR Creatinine clearance at least 60 mL/min Cardiovascular No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Gastrointestinal No history of peptic ulcer disease No gastrointestinal bleeding within the past 3 months Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior allergic reactions to compounds of similar chemical or biological composition to study drugs or to sulfonamides No prior allergic reaction, asthma, or urticaria after taking aspirin or NSAIDs No ongoing or active infection No other uncontrolled illness No psychiatric illness or social situation that would preclude study compliance No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy for metastatic pancreatic cancer More than 6 months since prior neoadjuvant or adjuvant chemoradiotherapy (including gemcitabine) for pancreatic cancer Endocrine therapy Not specified Radiotherapy See Chemotherapy More than 6 months since prior radiotherapy Surgery Not specified Other More than 30 days since prior investigational agents No other concurrent investigational or commercial agents or therapies for the malignancy No other concurrent nonsteroidal anti-inflammatory drugs (NSAIDs) No other concurrent cyclo-oxygenase-2 (COX-2) inhibitors (e.g., rofecoxib) Concurrent acetaminophen-containing medications or low-dose aspirin (up to 325 mg/day) for cardiac prophylaxis allowed

Sites / Locations

  • Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
  • M.D. Anderson Cancer Center - Orlando
  • CCOP - Atlanta Regional
  • CCOP - Carle Cancer Center
  • CCOP - Wichita
  • CCOP - Kansas City
  • CCOP - Cancer Research for the Ozarks
  • CCOP - Dayton
  • CCOP - Columbia River Oncology Program
  • M.D. Anderson Cancer Center at University of Texas
  • All Saints Cancer Center at All Saints Healthcare

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gemcitabine + Celecoxib

Arm Description

Oral celecoxib twice daily on days 1-28. Gemcitabine by vein (IV) over 65 minutes on days 1, 8 and 15. Courses repeat every 4 weeks.

Outcomes

Primary Outcome Measures

Overall Survival at 6 months

Secondary Outcome Measures

Overall response rate

Full Information

First Posted
September 10, 2003
Last Updated
October 30, 2018
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00068432
Brief Title
Gemcitabine and Celecoxib in Treating Patients With Metastatic Pancreatic Cancer
Official Title
A Phase II Trial of Gemcitabine and Celecoxib as First-Line Treatment for Patients With Advanced Metastatic Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may stop the growth of pancreatic cancer by stopping blood flow to the tumor and blocking the enzymes necessary for tumor cell growth. Combining gemcitabine with celecoxib may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with celecoxib works in treating patients with metastatic pancreatic cancer.
Detailed Description
OBJECTIVES: Determine the overall survival at 6 months in patients with metastatic pancreatic cancer treated with gemcitabine and celecoxib. Determine the objective tumor response, progression-free survival, and median survival of patients treated with this regimen. Determine the safety and toxicity of this regimen in these patients. OUTLINE: This is a nonrandomized, open-label, multicenter study. Patients receive gemcitabine IV over 65 minutes on days 1, 8, and 15 and oral celecoxib twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for 6 months from study entry and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 8 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
recurrent pancreatic cancer, stage IV pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gemcitabine + Celecoxib
Arm Type
Experimental
Arm Description
Oral celecoxib twice daily on days 1-28. Gemcitabine by vein (IV) over 65 minutes on days 1, 8 and 15. Courses repeat every 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Other Intervention Name(s)
Celebrex
Intervention Description
Oral celecoxib twice daily on days 1-28. Courses repeat every 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine Hydrochloride
Other Intervention Name(s)
Gemcitabine, Gemzar
Intervention Description
Receive gemcitabine by vein (IV) over 65 minutes on days 1, 8 and 15. Courses repeat every 4 weeks.
Primary Outcome Measure Information:
Title
Overall Survival at 6 months
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Overall response rate
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic pancreatic cancer Radiographic evidence of disease No known brain metastases PATIENT CHARACTERISTICS: Age Any age Performance status ECOG 0-2 OR Karnofsky 60-100% Life expectancy Not specified Hematopoietic WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST/ALT no greater than 2.5 times ULN Renal Creatinine normal OR Creatinine clearance at least 60 mL/min Cardiovascular No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Gastrointestinal No history of peptic ulcer disease No gastrointestinal bleeding within the past 3 months Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior allergic reactions to compounds of similar chemical or biological composition to study drugs or to sulfonamides No prior allergic reaction, asthma, or urticaria after taking aspirin or NSAIDs No ongoing or active infection No other uncontrolled illness No psychiatric illness or social situation that would preclude study compliance No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy for metastatic pancreatic cancer More than 6 months since prior neoadjuvant or adjuvant chemoradiotherapy (including gemcitabine) for pancreatic cancer Endocrine therapy Not specified Radiotherapy See Chemotherapy More than 6 months since prior radiotherapy Surgery Not specified Other More than 30 days since prior investigational agents No other concurrent investigational or commercial agents or therapies for the malignancy No other concurrent nonsteroidal anti-inflammatory drugs (NSAIDs) No other concurrent cyclo-oxygenase-2 (COX-2) inhibitors (e.g., rofecoxib) Concurrent acetaminophen-containing medications or low-dose aspirin (up to 325 mg/day) for cardiac prophylaxis allowed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry Q. Xiong, MD, PhD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72913
Country
United States
Facility Name
M.D. Anderson Cancer Center - Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806-2134
Country
United States
Facility Name
CCOP - Atlanta Regional
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342-1701
Country
United States
Facility Name
CCOP - Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
CCOP - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214-3882
Country
United States
Facility Name
CCOP - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
CCOP - Cancer Research for the Ozarks
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
CCOP - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
CCOP - Columbia River Oncology Program
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
M.D. Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
All Saints Cancer Center at All Saints Healthcare
City
Racine
State/Province
Wisconsin
ZIP/Postal Code
53405
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
UT MD Anderson Cancer Center Website

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Gemcitabine and Celecoxib in Treating Patients With Metastatic Pancreatic Cancer

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