Clinical trial · Interventional
Gemcitabine and Celecoxib in Treating Patients With Metastatic Pancreatic Cancer
A Phase II Trial of Gemcitabine and Celecoxib as First-Line Treatment for Patients With Advanced Metastatic Pancreatic Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may stop the growth of pancreatic cancer by stopping blood flow to the tumor and blocking the enzymes necessary for tumor cell growth. Combining gemcitabine with celecoxib may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with celecoxib works in treating patients with metastatic pancreatic cancer.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Celecoxib | Drug | Celecoxib | ALIAS |
| Gemcitabine Hydrochloride | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gemcitabine + Celecoxib
- description
- Oral celecoxib twice daily on days 1-28. Gemcitabine by vein (IV) over 65 minutes on days 1, 8 and 15. Courses repeat every 4 weeks.
- interventionNames
- Drug: Celecoxib
- Drug: Gemcitabine Hydrochloride
Primary outcomes (1)
- measure
- Overall Survival at 6 months
- timeFrame
- 6 Months
Secondary outcomes (1)
- measure
- Overall response rate
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed metastatic pancreatic cancer * Radiographic evidence of disease * No known brain metastases PATIENT CHARACTERISTICS: Age * Any age Performance status * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy * Not specified Hematopoietic * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST/ALT no greater than 2.5 times ULN Renal * Creatinine normal OR * Creatinine clearance at least 60 mL/min Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Gastrointestinal * No history of peptic ulcer disease * No gastrointestinal bleeding within the past 3 months Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No prior allergic reactions to compounds of similar chemical or biological composition to study drugs or to sulfonamides * No prior allergic reaction, asthma, or urticaria after taking aspirin or NSAIDs * No ongoing or active infection * No other uncontrolled illness * No psychiatric illness or social situation that would preclude study compliance * No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for metastatic pancreatic cancer * More than 6 months since prior neoadjuvant or adjuvant chemoradiotherapy (including gemcitabine) for pancreatic cancer Endocrine therapy * Not specified Radiotherapy * See Chemotherapy * More than 6 months since prior radiotherapy Surgery * Not specified Other * More than 30 days since prior investigational agents * No other concurrent investigational or commercial agents or therapies for the malignancy * No other concurrent nonsteroidal anti-inflammatory drugs (NSAIDs) * No other concurrent cyclo-oxygenase-2 (COX-2) inhibitors (e.g., rofecoxib) * Concurrent acetaminophen-containing medications or low-dose aspirin (up to 325 mg/day) for cardiac prophylaxis allowed
References
Publications (0)
Data not yet available