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

September 10, 2003
January 9, 2012
December 2003
July 2005   (final data collection date for primary outcome measure)
Overall Survival at 6 months [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00068432 on ClinicalTrials.gov Archive Site
Overall response rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Gemcitabine and Celecoxib in Treating Patients With Metastatic Pancreatic Cancer
A Phase II Trial of Gemcitabine and Celecoxib as First-Line Treatment for Patients With Advanced Metastatic Pancreatic Cancer

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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Cancer
  • 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
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.
Interventions:
  • Drug: Celecoxib
  • Drug: Gemcitabine Hydrochloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
July 2005
July 2005   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00068432
2003-0288, P30CA016672, MDA-2003-0288, NCI-6167, CDR0000322827
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Henry Q. Xiong, MD, PhD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP