Celecoxib, Irinotecan and Concurrent Radiotherapy in Preoperative Pancreatic Cancer

NCT00177853 | Terminated Phase 1 DMC

• 1 other identifier: 02-128
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Cancer

Keywords

Locally advanced pancreatic cancer; invasion of major arteries and veins around pancreas; No prior radiation or chemo

Outcome Measures

Primary Outcomes (1)

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

  12 weeks

Secondary Outcomes (1)

• Tumor diminishment for safe excision

  75 days

Study Arms (1)

1

EXPERIMENTAL

Celecoxib, Irinotecan and Concurrent Radiotherapy

Drug: celecoxib; Drug: irinotecan; Procedure: concurrent radiotherapy

Interventions

celecoxib DRUG

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.

Also known as: Celebrex

1

irinotecan DRUG

Preoperative chemoradiation will consist of escalating doses of irinotecan (30 50 mg/m2 IV) once weekly for a total of 4 doses.

Also known as: Camptosar

1

concurrent radiotherapy PROCEDURE

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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• Pharmacia and Upjohn: collaborator

Study Sites (1)

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Celecoxib; Irinotecan

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Camptothecin; Alkaloids

Study Officials

• A. J. Moser, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: December 1, 2006
• Primary Completion: December 1, 2006
• Study Completion: July 1, 2010
• Last Updated: July 2, 2010

Record last verified: 2010-07

Locations

US (1)