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Gemcitabine and Celecoxib in Treating Patients With Metastatic Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00068432
Recruitment Status : Completed
First Posted : September 11, 2003
Last Update Posted : October 31, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Celecoxib Drug: Gemcitabine Hydrochloride Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Gemcitabine and Celecoxib as First-Line Treatment for Patients With Advanced Metastatic Pancreatic Cancer
Study Start Date : December 2003
Actual Primary Completion Date : July 2005
Actual Study Completion Date : July 2005

Arm Intervention/treatment
Experimental: Gemcitabine + Celecoxib
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.
Drug: Celecoxib
Oral celecoxib twice daily on days 1-28. Courses repeat every 4 weeks.
Other Name: Celebrex

Drug: Gemcitabine Hydrochloride
Receive gemcitabine by vein (IV) over 65 minutes on days 1, 8 and 15. Courses repeat every 4 weeks.
Other Names:
  • Gemcitabine
  • Gemzar

Primary Outcome Measures :
  1. Overall Survival at 6 months [ Time Frame: 6 Months ]

Secondary Outcome Measures :
  1. Overall response rate [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed metastatic pancreatic cancer
  • Radiographic evidence of disease
  • No known brain metastases



  • Any age

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • Not specified


  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST/ALT no greater than 2.5 times ULN


  • Creatinine normal OR
  • Creatinine clearance at least 60 mL/min


  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia


  • No history of peptic ulcer disease
  • No gastrointestinal bleeding within the past 3 months


  • 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


Biologic therapy

  • Not specified


  • 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


  • See Chemotherapy
  • More than 6 months since prior radiotherapy


  • Not specified


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00068432

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United States, Arkansas
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
Fort Smith, Arkansas, United States, 72913
United States, Florida
M.D. Anderson Cancer Center - Orlando
Orlando, Florida, United States, 32806-2134
United States, Georgia
CCOP - Atlanta Regional
Atlanta, Georgia, United States, 30342-1701
United States, Illinois
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
United States, Missouri
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807
United States, Ohio
CCOP - Dayton
Dayton, Ohio, United States, 45429
United States, Oregon
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
United States, Texas
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
United States, Wisconsin
All Saints Cancer Center at All Saints Healthcare
Racine, Wisconsin, United States, 53405
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
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Principal Investigator: Henry Q. Xiong, MD, PhD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00068432     History of Changes
Other Study ID Numbers: 2003-0288
P30CA016672 ( U.S. NIH Grant/Contract )
MDA-2003-0288 ( Other Identifier: UT MD Anderson Cancer Center )
CDR0000322827 ( Registry Identifier: NCI PDQ )
First Posted: September 11, 2003    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Keywords provided by M.D. Anderson Cancer Center:
recurrent pancreatic cancer
stage IV pancreatic cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors