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


Phase 1
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

Thank you

Trial Information

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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

12 weeks

Safety Issue:

Yes

Principal Investigator

A. J. Moser, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh Medical Center Department of Surgery, Division of Surgical Oncology

Authority:

United States: Institutional Review Board

Study ID:

02-128

NCT ID:

NCT00177853

Start Date:

December 2006

Completion Date:

July 2010

Related Keywords:

  • Pancreatic Cancer
  • Locally advanced pancreatic cancer
  • invasion of major arteries and veins around pancreas
  • No prior radiation or chemo
  • Pancreatic Neoplasms

Name

Location

UPMC Hillman Cancer CenterPittsburgh, Pennsylvania  15232