Clinical trial · Interventional
Celecoxib, Capecitabine, and Irinotecan in Treating Patients With Recurrent or Metastatic Colorectal Cancer
Phase II Study of Celecoxib, Capecitabine, and Irinotecan in Patients With Metastatic Colorectal Cancer
NCT00258232CI-TRIAL-00009945completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as capecitabine and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving celecoxib together with capecitabine and irinotecan may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving celecoxib together with capecitabine and irinotecan works in treating patients with recurrent or metastatic colorectal 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| celecoxib | Drug | Celecoxib | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response rate by RECIST criteria at every other course
Secondary outcomes (4)
- measure
- Time to progression
- measure
- Toxicity
- measure
- Overall survival
- measure
- Time to treatment failure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the colon or rectum * Locally recurrent or metastatic disease * Measurable disease, defined as ≥ 1 measurable lesion ≥ 20 mm by conventional CT scan OR ≥ 10 mm by spiral CT scan * Bone metastases, ascites, and pleural effusion are not considered measurable disease * Measurable lesions must be located outside a previously irradiated field PATIENT CHARACTERISTICS: Performance status * SWOG 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin normal * No Gilbert's disease Renal * Creatinine clearance \> 50 mL/min Cardiovascular * No clinically significant cardiac disease that is not well controlled by medication, including any of the following conditions: * Congestive heart failure * Symptomatic coronary artery disease * Cardiac arrhythmias * No myocardial infarction within the past year Gastrointestinal * Must have a physically intact upper gastrointestinal tract * Able to swallow tablets * No history of peptic ulcer disease or gastroesophageal reflux * No malabsorption syndrome Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No known HIV positivity * No asthma, urticaria, or allergic-type reaction after prior treatment with aspirin or other nonsteroidal anti-inflammatory drugs * No other malignancy except curatively treated cancer with no evidence of active disease * No unresolved bacterial infection requiring antibiotics * No other serious infection * No known allergy to study drugs or sulfa drugs PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for colorectal cancer * Patients relapsing \> 6 months after completion of prior adjuvant chemotherapy allowed * No other concurrent anticancer chemotherapy Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * At least 3 weeks since prior radiotherapy * No concurrent anticancer radiotherapy Surgery * Recovered from prior surgery * No concurrent anticancer surgery Other * Prior celecoxib for nonmalignant disorders allowed * No other concurrent cyclooxygenase-2 inhibitors or nonsteroidal anti-inflammatory drugs, including any of the following: * Rofecoxib * Ibuprofen * Naproxen * Etodolac * Oxaprozin * Diflunisal * Nabumetone * Tolmetin
References
Publications (1)
- RESULTEl-Rayes BF, Venkat R, Heilbrun LK: A dose attenuated schedule of irinotecan and capecitabine in combination with celecoxib in advanced colorectal cancer. [Abstract] American Society of Clinical Oncology 2006 Gastrointestinal Cancers Symposium, 26-28 January 2006, San Francisco, California. A-254, 2006.