Celecoxib, Irinotecan and Concurrent Radiotherapy in Preoperative Pancreatic Cancer
Information source: University of Pittsburgh
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pancreatic Cancer
Intervention: celecoxib (Drug); irinotecan (Drug); concurrent radiotherapy (Procedure)
Phase: Phase 1
Status: Active, not recruiting
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: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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: March 2003
Ending date: December 2008
Last updated: June 2, 2008
|
