Clinical trial NCT00177853: Celecoxib, Irinotecan and Concurrent Radiotherapy in Preoperative Pancreatic Cancer
Official title: A Phase I Study of Celecoxib, Irinotecan and Concurrent Radiotherapy in the Preoperative Treatment of Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Pancreatic Cancer
Keywords: Locally advanced pancreatic cancer
invasion of major arteries and veins around pancreas
No prior radiation or chemo
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Pharmacia and Upjohn
First posted: 2005-09-15
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Determine efficacy of combination of irinotecan, celecoxib and concurrent radiotherapy on pancreatic cancer; determine highest/safest doses of these drugs
timeFrame: 12 weeks
Secondary outcomes:
measure: Tumor diminishment for safe excision
timeFrame: 75 days
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh Medical Center Department of Surgery, Division of Surgical Oncology
name: A. J. Moser, MD
role: PRINCIPAL_INVESTIGATOR
References: