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Celecoxib, Irinotecan and Concurrent Radiotherapy in Preoperative Pancreatic Cancer

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University of Pittsburgh

Status and phase

Terminated
Phase 1

Conditions

Pancreatic Cancer

Treatments

Drug: irinotecan
Procedure: concurrent radiotherapy
Drug: celecoxib

Study type

Interventional

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

23 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

23 participants in 1 patient group

1
Experimental group
Description:
Celecoxib, Irinotecan and Concurrent Radiotherapy
Treatment:
Drug: celecoxib
Procedure: concurrent radiotherapy
Drug: irinotecan

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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