Celecoxib, Irinotecan and Concurrent Radiotherapy in Preoperative Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

A Phase I Study of Celecoxib, Irinotecan and Concurrent Radiotherapy in the Preoperative Treatment of Pancreatic Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00177853
• Other study ID #: 02-128
• Status: Terminated
• Phase: Phase 1
• First received: September 13, 2005
• Last updated: July 1, 2010
• Start date: December 2006
• Est. completion date: July 2010

Study information

• Verified date: July 2010
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: July 2010
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Pharmacia and Upjohn

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine efficacy of combination of irinotecan, celecoxib and concurrent radiotherapy on pancreatic cancer; determine highest/safest doses of these drugs		12 weeks	Yes
Secondary	Tumor diminishment for safe excision		75 days	No