Celecoxib, Irinotecan and Concurrent Radiotherapy in Preoperative Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT00177853|
Recruitment Status : Terminated (terminated)
First Posted : September 15, 2005
Last Update Posted : July 2, 2010
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: celecoxib Drug: irinotecan Procedure: concurrent radiotherapy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Celecoxib, Irinotecan and Concurrent Radiotherapy in the Preoperative Treatment of Pancreatic Cancer|
|Study Start Date :||December 2006|
|Actual Primary Completion Date :||December 2006|
|Actual Study Completion Date :||July 2010|
Celecoxib, Irinotecan and Concurrent Radiotherapy
Patients will start celecoxib (200mg PO BID) beginning 3-5 days prior to chemoradiation at home and receive the drug until 30 days following the completion of chemoradiation.
Other Name: Celebrex
Preoperative chemoradiation will consist of escalating doses of irinotecan (30 50 mg/m2 IV) once weekly for a total of 4 doses.
Other Name: Camptosar
Procedure: concurrent radiotherapy
50.4 cGy of standard external beam radiation. The radiation will be given in 28 treatments of 1.8 cGy per treatment over 5.5 weeks. This will be given in an outpatient setting.
- Determine efficacy of combination of irinotecan, celecoxib and concurrent radiotherapy on pancreatic cancer; determine highest/safest doses of these drugs [ Time Frame: 12 weeks ]
- Tumor diminishment for safe excision [ Time Frame: 75 days ]
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 ClinicalTrials.gov identifier (NCT number): NCT00177853
|United States, Pennsylvania|
|UPMC Hillman Cancer Center|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||A. J. Moser, MD||University of Pittsburgh Medical Center Department of Surgery, Division of Surgical Oncology|