Gemcitabine and Celecoxib in Treating Patients With Metastatic Pancreatic Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00068432
First received: September 10, 2003
Last updated: January 9, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
Pancreatic Cancer
Drug: Celecoxib
Drug: Gemcitabine Hydrochloride
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Overall Survival at 6 months [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: December 2003
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00068432

Locations
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
Investigators
Principal Investigator: Henry Q. Xiong, MD, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00068432     History of Changes
Other Study ID Numbers: 2003-0288, P30CA016672, MDA-2003-0288, NCI-6167, CDR0000322827
Study First Received: September 10, 2003
Last Updated: January 9, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
recurrent pancreatic cancer
stage IV pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Celecoxib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 26, 2014