Celecoxib, Irinotecan and Concurrent Radiotherapy in Preoperative Pancreatic Cancer
This study has been terminated.
(terminated)
Sponsor:
University of Pittsburgh
Collaborator:
Pharmacia and Upjohn
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00177853
First received: September 13, 2005
Last updated: July 1, 2010
Last verified: July 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Drug: celecoxib Drug: irinotecan Procedure: concurrent radiotherapy |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study of Celecoxib, Irinotecan and Concurrent Radiotherapy in the Preoperative Treatment of Pancreatic Cancer |
Resource links provided by NLM:
Further study details as provided by University of Pittsburgh:
Primary Outcome Measures:
- Determine efficacy of combination of irinotecan, celecoxib and concurrent radiotherapy on pancreatic cancer; determine highest/safest doses of these drugs [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Tumor diminishment for safe excision [ Time Frame: 75 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 23 |
| Study Start Date: | December 2006 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Celecoxib, Irinotecan and Concurrent Radiotherapy
|
Drug: celecoxib
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.
Other Name: Celebrex
Drug: irinotecan
Preoperative chemoradiation will consist of escalating doses of irinotecan (30 50 mg/m2 IV) once weekly for a total of 4 doses.
Other Name: Camptosar
Procedure: concurrent 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.
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00177853
Locations
| United States, Pennsylvania | |
| UPMC Hillman Cancer Center | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
Sponsors and Collaborators
University of Pittsburgh
Pharmacia and Upjohn
Investigators
| Principal Investigator: | A. J. Moser, MD | University of Pittsburgh Medical Center Department of Surgery, Division of Surgical Oncology |
More Information
No publications provided
| Responsible Party: | A. James Moser, MD, UPCI |
| ClinicalTrials.gov Identifier: | NCT00177853 History of Changes |
| Other Study ID Numbers: | 02-128 |
| Study First Received: | September 13, 2005 |
| Last Updated: | July 1, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Pittsburgh:
|
Locally advanced pancreatic cancer invasion of major arteries and veins around pancreas No prior radiation or chemo |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Irinotecan Celecoxib Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents |
Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Central Nervous System Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 19, 2013