Clinical trial · Interventional
Celecoxib in Treating Patients With Early-Stage Rectal Cancer
Pilot COX-2 Activity in Early Stage Rectal Cancer -Short Term Administration of Celecoxib (SPORE)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low accrual
Summary
Brief summary (as posted)
RATIONALE: Studying samples of tissue, blood, and urine from patients with cancer in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how rectal cancer will respond to treatment with celecoxib. PURPOSE: This clinical trial is studying how well celecoxib works in treating patients with early-stage rectal 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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biopsy | Procedure | — | UNRESOLVED |
| celecoxib | Drug | Celecoxib | ALIAS |
| gene expression analysis | Genetic | — | UNRESOLVED |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| mass spectrometry | Other | — | UNRESOLVED |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| protein expression analysis | Genetic | — | UNRESOLVED |
| therapeutic conventional surgery |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Therapeutic Intervention/Celecoxib
- description
- Celecoxib
- interventionNames
- Drug: celecoxib
- Genetic: gene expression analysis
- Genetic: protein expression analysis
- Other: immunohistochemistry staining method
- Other: laboratory biomarker analysis
- Other: mass spectrometry
- Procedure: biopsy
- Procedure: neoadjuvant therapy
- Procedure: therapeutic conventional surgery
Primary outcomes (4)
- measure
- Event rate of over-expression of cyclooxygenase-2
- timeFrame
- Pre and post 7 days administration of study drug
- measure
- Percent change of eicosanoid level
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Clinical diagnosis of primary adenocarcinoma of the rectum (to be histologically confirmed upon study entry) * Tumor must be at or below the peritoneal reflection * The distal border of the tumor is within 12 cm of the anal verge on proctoscopic examination * Clinically resectable disease PATIENT CHARACTERISTICS: * Karnofsky performance status 60-100% * WBC ≥ 4,000/mm³ * Platelet count ≥ 150,000/mm³ * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other serious medical illness (other than rectal cancer) that would preclude study therapy * No psychiatric condition that would preclude informed consent * No history of allergy to celecoxib or any other NSAIDs, including acetylsalicylic acid (i.e., aspirin), ibuprofen, or indomethacin * No history of allergy to sulfonamides Exclusion criteria: Not noted PRIOR CONCURRENT THERAPY: * At least 7 days since prior and no concurrent NSAIDs or other cyclooxygenase-2 inhibitors * No concurrent warfarin, except low-dose warfarin (i.e., 1 mg/day) administered for prophylaxis
References
Publications (0)
Data not yet available