Celecoxib, Irinotecan and Concurrent Radiotherapy in Preoperative Pancreatic Cancer

Stopped early · Phase 1

Conditions studied: Pancreatic Cancer

In brief

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.

Key facts

Study ID

NCT00177853

Run by

University of Pittsburgh

People needed

23

Starts

2006-12-01

Expected to finish

2010-07-01

Last updated by the study team

2010-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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