Gemcitabine and Celecoxib in Treating Patients With Metastatic Pancreatic Cancer

Tracking Information
First Submitted Date ICMJE	September 10, 2003
First Posted Date ICMJE	September 11, 2003
Last Update Posted Date	January 11, 2012
Study Start Date ICMJE	December 2003
Actual Primary Completion Date	July 2005 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: May 27, 2010)	Overall Survival at 6 months [ Time Frame: 6 Months ]
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00068432 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: May 27, 2010)	Overall response rate [ Time Frame: 6 months ]
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Gemcitabine and Celecoxib in Treating Patients With Metastatic Pancreatic Cancer
Official Title ICMJE	A Phase II Trial of Gemcitabine and Celecoxib as First-Line Treatment for Patients With Advanced Metastatic Pancreatic Cancer
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.
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Pancreatic Cancer
Intervention ICMJE	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
Study Arms	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: May 27, 2010)	28
Original Enrollment ICMJE	Not Provided
Actual Study Completion Date	July 2005
Actual Primary Completion Date	July 2005 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	Child, Adult, Older Adult
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00068432
Other Study ID Numbers ICMJE	2003-0288; P30CA016672 ( U.S. NIH Grant/Contract ); MDA-2003-0288 ( Other Identifier: UT MD Anderson Cancer Center ); NCI-6167; CDR0000322827 ( Registry Identifier: NCI PDQ )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	M.D. Anderson Cancer Center
Study Sponsor ICMJE	M.D. Anderson Cancer Center
Collaborators ICMJE	National Cancer Institute (NCI)
Investigators ICMJE	Principal Investigator: Henry Q. Xiong, MD, PhD M.D. Anderson Cancer Center
PRS Account	M.D. Anderson Cancer Center
Verification Date	January 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP