Clinical trial · Interventional
Celecoxib, Irinotecan and Concurrent Radiotherapy in Preoperative Pancreatic Cancer
A Phase I Study of Celecoxib, Irinotecan and Concurrent Radiotherapy in the Preoperative Treatment of Pancreatic Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): terminated
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| celecoxib | Drug | Celecoxib | ALIAS |
| concurrent radiotherapy | Procedure | — | UNRESOLVED |
| irinotecan | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Celecoxib, Irinotecan and Concurrent Radiotherapy
- interventionNames
- Drug: celecoxib
- Drug: irinotecan
- Procedure: concurrent radiotherapy
Primary outcomes (1)
- 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 (1)
- measure
- Tumor diminishment for safe excision
- timeFrame
- 75 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available