Pancreas Neoplasms Clinical Trial
Official title:
A Phase II Trial of Celecoxib in Patients With IPMN
The purpose of the study is to find out whether the drug celecoxib has beneficial effects on people with pre-cancerous lesions of the pancreas.
Efforts at finding a successful chemotherapy for pancreatic cancer have been disappointing.
Some patients are at increased risk of pancreatic cancer or may have pre-malignant
pancreatic lesions which predispose them to later pancreatic cancer development. In these
individuals, chemopreventative measures may block future development of pancreatic cancer.
Human tissue studies, cell culture and animal models of pancreatic cancer strongly suggests
that cyclooxygenase-2 (COX-2) may be a successful target for chemoprevention. COX-2 is
overexpressed in human pancreatic cancers. Elevated COX-2 expression correlates with
progression of premalignant precursors of pancreatic cancer in development models of hamster
pancreatic cancer. Human tissue studies confirm increases in COX-2 expression with
progression of premalignant precursors called intraductal papillary mucinous neoplasms
(IPMNs) and pancreatic intraepithelial neoplasms (PanINs). Moreover, COX-2 inhibitors appear
to have chemopreventative efficacy in the PC-1 homograft model of hamster pancreatic cancer.
Demographic studies have suggested COX-2 inhibitors may confer protection from pancreatic
cancer. We propose to conduct a pilot/phase II trial to determine the chemopreventative
effects of the COX-2 inhibitor celecoxib in patients with premalignant pancreatic lesions.
Patients registered to the study will take celecoxib twice daily for 6-8 weeks prior to
surgery (if patient decides to have surgery for his/her condition). If subject is not a
surgical candidate or puts off surgical treatment, subject will take celecoxib for 6 months.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01774162 -
EUS-guided Fine Needle Biopsy With a New Core Histology Needle Versus Conventional Fine Needle Aspiration
|
N/A | |
| Completed |
NCT00930410 -
Intra-ductal Confocal Endomicroscopy for Characterization of Pancreas and Bile Duct Tumor
|
N/A | |
| Completed |
NCT00377936 -
EndoTAG-1 / Gemcitabine Combination Therapy to Treat Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas
|
Phase 2 | |
| Active, not recruiting |
NCT02905578 -
A Phase 2 Trial of High-dose Ascorbate for Pancreatic Cancer (PACMAN 2.1)
|
Phase 2 | |
| Completed |
NCT01446458 -
Phase I Study of Stereotactic Body Radiation Therapy and FOLFIRINOX in the Neoadjuvant Therapy of Pancreatic Cancer
|
Phase 1 | |
| Recruiting |
NCT02789371 -
Comparing of Modified Wet Suction Technique and Dry Suction Technique for EUS-FNA of Solid Occupying Lesions
|
N/A | |
| Unknown status |
NCT00683358 -
Human Leukocyte Antigen-A*2402-Restricted Tumor Vessel Specific Peptide Vaccination for Advanced Pancreatic Cancer
|
Phase 1/Phase 2 | |
| Terminated |
NCT00683085 -
Human Leukocyte Antigen-A*02:01-restricted Tumor Vessel Specific Peptide Vaccination for Advanced Pancreatic Cancer
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT03803930 -
Comparing of a 22G EUS Procore Fine Needle Biopsy Device and a 20G EUS Procore Fine Needle Biopsy Device
|
N/A | |
| Completed |
NCT02681796 -
Epidural Analgesia Use in Pancreatic Resections
|
Phase 1 | |
| Recruiting |
NCT00690300 -
Docetaxel Plus Oxaliplatin as Therapy in Patients With Pancreatic Cancer
|
Phase 2 | |
| Recruiting |
NCT02327065 -
Prospective Multi-center, Single Blinded, Randomized, Controlled Trial of EUS-FNB and EUS-FNA on Solid Occupying Lesion
|
N/A | |
| Completed |
NCT01693419 -
S-1, Gemcitabine and Erlotinib for Advanced Pancreatic Cancer
|
Phase 2 |