Celecoxib, Irinotecan and Concurrent Radiotherapy in Preoperative Pancreatic Cancer
- Conditions
- Pancreatic Cancer
- Interventions
- Registration Number
- NCT00177853
- Lead Sponsor
- University of Pittsburgh
- Brief Summary
The purposes of this study are to examine the effects of a new combination of drugs, celecoxib (Celebrex®) and irinotecan (CPT-11), with standard radiation therapy on people before they undergo surgery; to determine what effects this combination has on pancreatic cancer; and to determine the highest dose of celecoxib and irinotecan that can be given safely without causing severe side effects. While not an endpoint, it is hoped that this combination will also shrink tumors enough for excision.
- Detailed Description
The purposes of this study are to examine the effects of a new combination of drugs, celecoxib (Celebrex®) and irinotecan (CPT-11), with standard radiation therapy on people before they undergo surgery; to determine what effects this combination has on pancreatic cancer; and to determine the highest dose of celecoxib and irinotecan that can be given safely without causing severe side effects. While not an endpoint, it is hoped that this combination will also shrink tumors enough for excision.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 23
- Locally advanced carcinoma of the pancreas
- Arterial invasion or encasement
- Invasion/encasement of the portomesenteric veins
- Patients who have been previously denied operation
- Obstructive jaundice must be drained with a polyethylene biliary stent or surgical bypass prior to beginning treatment.
- White blood cell count > 3500 per ml and platelet count > 100,000 per ml
- Serum creatinine ≤ 1.5 mg/dl
- Bilirubin ≤ 1.5
- ECOG performance status < 2
- Prior chemotherapy, radiotherapy, or investigational agents for pancreatic cancer
- Evidence of distant metastasis or malignant lymphadenopathy
- Concurrent malignancies
- History of allergic reactions to celecoxib or to sulfa drugs
- No non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, magnesium or aluminum containing antacids, fluconazole or lithium may be administered within 5 days of study entry, during the study and for the 30 days following the completion of all study treatments.
- Pregnant women and lactating women
- Uncontrolled or serious intercurrent illness
- HIV-positive patients receiving combination antiretroviral therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 celecoxib Celecoxib, Irinotecan and Concurrent Radiotherapy 1 concurrent radiotherapy Celecoxib, Irinotecan and Concurrent Radiotherapy 1 irinotecan Celecoxib, Irinotecan and Concurrent Radiotherapy
- Primary Outcome Measures
Name Time Method Determine efficacy of combination of irinotecan, celecoxib and concurrent radiotherapy on pancreatic cancer; determine highest/safest doses of these drugs 12 weeks
- Secondary Outcome Measures
Name Time Method Tumor diminishment for safe excision 75 days
Trial Locations
- Locations (1)
UPMC Hillman Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States