Pancreatic Cancer
Conditions
Keywords
Locally advanced pancreatic cancer, invasion of major arteries and veins around pancreas, No prior radiation or chemo
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.
Interventions
DRUGcelecoxib
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.
DRUGirinotecan
Preoperative chemoradiation will consist of escalating doses of irinotecan (30 50 mg/m2 IV) once weekly for a total of 4 doses.
PROCEDUREconcurrent radiotherapy
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.
Sponsors
Pharmacia and Upjohn
University of Pittsburgh
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine efficacy of combination of irinotecan, celecoxib and concurrent radiotherapy on pancreatic cancer; determine highest/safest doses of these drugs | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Tumor diminishment for safe excision | 75 days |
Countries
United States
Outcome results
None listed