DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Celecoxib, Irinotecan and Concurrent Radiotherapy in Preoperative Pancreatic Cancer

Information source: University of Pittsburgh
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pancreatic Cancer

Intervention: celecoxib (Drug); irinotecan (Drug); concurrent radiotherapy (Procedure)

Phase: Phase 1

Status: Terminated

Sponsored by: University of Pittsburgh

Official(s) and/or principal investigator(s):
A. J. Moser, MD, Principal Investigator, Affiliation: University of Pittsburgh Medical Center Department of Surgery, Division of Surgical Oncology

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.

Clinical Details

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

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

Primary outcome: Determine efficacy of combination of irinotecan, celecoxib and concurrent radiotherapy on pancreatic cancer; determine highest/safest doses of these drugs

Secondary outcome: Tumor diminishment for safe 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania 15232, United States
Additional Information

Starting date: December 2006
Last updated: July 1, 2010

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017