A Trial of Maintenance ADAPT Therapy With Capecitabine and Celecoxib in Patients With Metastatic Colorectal Cancer

Exclusion Criteria

• •History of allergies to sulfonamide, aspirin, any nonsteroidal anti-inflammatory drugs (NSAIDS), 5-FU or celecoxib
• •Prior 5-FU-based adjuvant chemotherapy less than 6 months prior to beginning ADAPT therapy and any residual neuropathy \> grade 2
• •Any regular use of cyclooxygenase-2 (COX-2) inhibitors as defined by 2-3 times per week
• •Use of aspirin is NOT an exclusion criterion as long as the daily dose does not exceed 325 mg daily; initiation of ADAPT therapy requires patient to discontinue aspirin for 18 months
• •Pregnant or lactating women
• •History of significant neurologic or psychiatric disorders, including dementia or seizures that would impede consent, treatment, or follow up
• •Any serious illness or medical condition that could affect participation on trial
• •Any uncontrolled congestive heart failure New York Heart Association class III or IV
• •Any uncontrolled hypertension, arrhythmia, or active angina pectoris
• •Any history of major myocardial infarction, stroke or transient ischemic attack (TIA); minor acute myocardial infarction (AMI) and patients who have had cardiac bypass free of symptoms for at least 2 years may be eligible at the discretion of the study chair
• •Serious uncontrolled active infection
• •Patients with creatinine clearance: \< 50 mL/min are excluded from this protocol; capecitabine is contraindicated in severe renal impairment (clearance \< 40 mL/min)
• •Inability to swallow oral medications or any medical conditions that may affect intestinal absorption of the study agent or inability to comply with oral medication
• •History of active peptic ulcer disease or major upper gastrointestinal (GI) bleed \< 12 months; history of GI bleeding from the colorectal cancer primary is not an exclusion criterion
• •Use of warfarin is not allowed; patient is recommended to switch to low molecular weight heparin (LMWH) before participating in this study
• •Patients with any history of brain or bone metastasis or who have developed progressive disease on first line 5-FU based therapy
• •Current use of systemic steroid medication
• •Patients with an obstructive synchronous colorectal tumor requiring up-front surgery or chemoradiation
• •Patients with partial or complete bowel obstruction due to abdominal carcinomatosis