Clinical trial · Interventional
Celecoxib, Leucovorin, Fluorouracil, and Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer
A Phase II Of An Optimized LV-5FU-Oxaliplatin Strategy With Celebrex In Metastatic Colorectal Cancer, Optimox2-Celecoxib Study
NCT00072553CI-TRIAL-00001991unknownPhase 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: Drugs used in chemotherapy, such as leucovorin, fluorouracil, and oxaliplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may stop the growth of colorectal cancer by stopping blood flow to the tumor and by blocking the enzymes necessary for tumor cell growth. Combining chemotherapy with celecoxib may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining celecoxib with leucovorin, fluorouracil, and oxaliplatin in treating patients who have 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 (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| celecoxib | Drug | Celecoxib | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response rate
Secondary outcomes (6)
- measure
- Toxicity
- measure
- Time of disease control (progression-free survival)
- measure
- Salvage surgery rate
- measure
- Duration of chemotherapy-free intervals
- measure
- Tolerability
- measure
- Quality of life
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the colon or rectum * Metastatic disease * Inoperable disease (i.e., not suitable for complete carcinological surgical resection) * Measurable disease or nonmeasurable disease * At least 1 unidimensionally measurable lesion at least 20 mm by conventional CT scan OR 10 mm by spiral CT scan * Nonmeasurable disease defined as all other lesions, including small lesions or truly nonmeasurable disease * No CNS metastases * No exclusive bone metastases * No symptomatic ascites or pleural effusion not evacuated before study entry PATIENT CHARACTERISTICS: Age * 18 to 75 Performance status * WHO 0-2 Life expectancy * Not specified Hematopoietic * Neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * No known significant bleeding disorder Hepatic * Alkaline phosphatase less than 3 times upper limit of normal (ULN) Renal * Creatinine less than 1.5 times ULN OR * Creatinine clearance at least 30 mL/min * No uncontrolled hypercalcemia Cardiovascular * No congestive heart failure Gastrointestinal * No total or partial bowel obstruction * No active gastric or duodenal ulceration or gastrointestinal bleeding within the past year * No active inflammatory bowel disease Other * Not pregnant or nursing * Fertile patients must use effective contraception * HIV negative * No peripheral sensory neuropathy * No known sensitivity to celecoxib, other COX-2 inhibitors, NSAIDs, salicylates, or sulfonamides * No AIDS-related illness * No active infection * No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer * No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * No prior immunotherapy for metastatic disease Chemotherapy * Prior adjuvant chemotherapy allowed provided the progression-free interval after completion of therapy is more than 6 months in duration * No prior chemotherapy for metastatic disease * No prior adjuvant oxaliplatin * No other concurrent chemotherapy Endocrine therapy * No concurrent chronic oral or IV corticosteroid use (i.e., 2 weeks or longer in duration) Radiotherapy * No concurrent radiotherapy Surgery * Not specified Other * More than 30 days since prior investigational drugs * No other concurrent investigational drugs or treatments * No concurrent prophylactic fluconazole * No concurrent chronic full-dose aspirin (at least 325 mg/day), other nonsteroidal anti-inflammatory drugs (NSAIDs), or other cyclooxygenase (COX)-2 inhibitors * Concurrent low-dose (cardioprotective) aspirin (80 mg/day or equivalent) allowed * No concurrent lithium * No other concurrent anticancer therapy
References
Publications (1)
- RESULTAndre T, Tournigand C, Mineur L, Fellague-Chebra R, Flesch M, Mabro M, Hebbar M, Postel Vinay S, Bidard FC, Louvet C, de Gramont A. Phase II study of an optimized 5-fluorouracil-oxaliplatin strategy (OPTIMOX2) with celecoxib in metastatic colorectal cancer: a GERCOR study. Ann Oncol. 2007 Jan;18(1):77-81. doi: 10.1093/annonc/mdl336. Epub 2006 Oct 9. PMID 17030548