Gemcitabine and Celecoxib in Treating Patients With Metastatic Pancreatic Cancer
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ClinicalTrials.gov Identifier: NCT00068432 |
Recruitment Status
:
Completed
First Posted
: September 11, 2003
Last Update Posted
: January 11, 2012
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Tracking Information | ||||
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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 |
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 |
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. |
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Detailed Description | OBJECTIVES:
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 ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Pancreatic Cancer | |||
Intervention ICMJE |
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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:
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
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:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Sex/Gender |
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Ages | Child, Adult, Senior | |||
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 ) |
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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 |
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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 |