Combination Chemotherapy Treatments in Patients With Metastatic Colorectal Cancer

Inclusion criteria

• Patient must have a histologically proven adenocarcinoma of colon or rectum with metastases or local recurrence.
• Patients must have at least one measurable lesion according to the RECIST criteria. Bone metastases, ascites and pleural effusion are not measurable.
• Minimum indicator lesion size as follows:

Greater than or equal to 20 mm measured by conventional CT Greater than or equal to 10 mm measured by spiral techniques

• Prior use of celecoxib for the treatment of nonmalignant disorders is allowed.
• Patients must have a performance status of 0,1, or 2 by the Southwest Oncology Group criteria.
• Patients must have a calculated creatinine clearance of greater than 50 ml/min.
• Patients must have an absolute neutrophil count of greater than or equal to 1500/ml, platelet count greater than or equal to 100,000/ml, and total serum bilirubin equal or less than the institution's upper limit or normal range.
• Patients must have recovered from any effects of surgery.
• Evaluable disease must be present outside radiation field. At least 3 weeks must have elapsed after discontinuation of radiation therapy.
• Patients must provide a signed consent to participate in the study.

Exclusion criteria

• Patients with a proven history of peptic ulcer disease or gastroesophageal reflux.
• Patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other non-steroidal anti-inflammatory drugs.
• Patients who have received prior chemotherapy for colorectal cancer (including capecitabine or irinotecan) except for patients relapsing more than 6 months after completion of adjuvant chemotherapy.
• History of other malignancy, except for cancers that have been treated with a curative intent and patient is without evidence of active disease.
• Unresolved bacterial infection requiring treatment with antibiotics.
• Pregnant or lactating women may not participate in the study. Women/men of reproductive age group may not participate unless they have agreed to use an effective method of contraception.
• Patients who have allergy to any of the study drugs or sulfa drugs.
• Patients known to have HIV-1 virus infection because of the undetermined effect of this chemotherapy regimen in patients with HIV-1 and the potential for serious interaction with anti-HIV medications.
• Gilbert's disease.
• Lack of physical integrity of the upper gastrointestinal tract. Inability to swallow tablets or those who have malabsorption syndrome.
• Other serious concurrent infection
• Clinically significant cardiac disease not well controlled with medication (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias) or myocardial infarction within the last 12 months.