Official Title: “A Phase I Study of Celecoxib, Irinotecan and Concurrent Radiotherapy in the Preoperative Treatment of Pancreatic Cancer”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2005

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.

Intervention(s) in this Clinical Trial

• Drug: celecoxib
  • 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.
• Drug: irinotecan
  • Preoperative chemoradiation will consist of escalating doses of irinotecan (30 50 mg/m2 IV) once weekly for a total of 4 doses.
• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Celecoxib, Irinotecan and Concurrent Radiotherapy

Primary Measures

• Determine efficacy of combination of irinotecan, celecoxib and concurrent radiotherapy on pancreatic cancer; determine highest/safest doses of these drugs
  • Time Frame: 12 weeks
    Safety Issue?: Yes

Secondary Measures

• Tumor diminishment for safe excision
  • Time Frame: 75 days
    Safety Issue?: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Pittsburgh

Overall Clinical Trial Officials and Contacts

A. J. Moser, MD Principal Investigator University of Pittsburgh Medical Center Department of Surgery, Division of Surgical Oncology  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00177853

Study ID Number: 02-128

ClinicalTrials.gov Identifier: NCT00177853

Health Authority: United States: Institutional Review Board