| | Requirement |
| 1 | Histologically confirmed metastatic adenocarcinoma of colon or rectum for which no further standard chemotherapy is considered effective. Malignancy must be confirmed by review of biopsy specimens by Division of Pathology of USC/LAC/Norris Cancer Center. |
| 2 | Must have failed (progressed on or were intolerant of) 5-FU, CPT-11, and/or oxaliplatin-based chemotherapy. |
| 3 | SWOG PS 0-1. |
| 4 | AGC >1.0; platelets >100,000. |
| 5 | Total bilirubin < / = 2 x uln; SGOT and/or SGPT < / = 2 x uln (< / = 5 x uln if with liver metastases). |
| 6 | Creatinine < / = 1.25 x uln. |
| 7 | Patients enrolled in Phase II portion of study must have measurable disease. |
| 8 | Patients who fulfill at least one of following criteria will be required to take low-dose aspirin throughout the study starting on the first day of study drug: (1) Age at least 65 years old; (2) HTN – SBP 160 or over or DBP 95 or over on separate occasions; (3) hypercholesterolemia – total blood cholesterol at least 240 mg/dl; (4) History of any of following – MI, unstable angina, CVA/TIA, PVD, smoking, strong family history – primary relative with MI under age 55. |
| 9 | Signed informed consent (including HIPAA authorization). |
| 1 | Prior investigational agent within 28 days of first day of study drug dosing. |
| 2 | History of another malignancy within 3 years prior to study entry, except curatively treated non-melanoma skin carcinoma, prostate cancer, or in-situ cervical cancer. |
| 3 | Another severe and/or life-threatening medical disease. |
| 4 | Acute or known chronic liver or kidney disease (e.g., chronic active hepatitis, cirrhosis, chronic renal insufficiency). |
| 5 | Known HIV infection. |
| 6 | Prior chemotherapy within 4 weeks (6 weeks for nitrosourea, mitomycin-C, or any antibody treatment). |
| 7 | Symptomatic brain metastases. |
| 8 | NYHA Class III or IV cardiac problems (e.g., CHF, MI within 6 months of study). |
| 9 | Medical, social, or psychological factors interfering with compliance. |
| 10 | Undergone major surgery for any cause <4 weeks prior to study entry. |
| 11 | Taking coumadin or other agent containing warfarin, except prophylactic low-dose coumadin 1 mg or less for maintenance of indwelling lines or ports. |
| 12 | Any peripheral neuropathy >Gr 1. |
| 13 | Unresolved diarrhea >Gr 1. |
| 14 | History of allergy to sulfonamide drugs. |
| 15 | Active PUD or other contraindications to chronic NSAID or aspirin use. |
| 16 | Lactose intolerance. |
| 17 | Taking full-dose NSAIDs, including aspirin regularly for any reason (e.g., arthritis, history of TIA or MI). Patients taking cardiac preventive dose ASA <81 mg daily are eligible. Patients should stop taking any other NSAIDs 14 days prior to receiving first dose of celecoxib. |
| 18 | Hypersensitivity to COX-2 inhibitors, NSAIDs, or salicylate. |
| 19 | Taking fluconazole or lithium. |
| 20 | Pregnant or lactating women. Female patients of childbearing potential must have a negative pregnancy test within 7 days before initiation of study drug dosing. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout study and for up to 3 months following discontinuation of study drug. |
