- Diagnosis of colorectal cancer (either newly diagnosed or recurrent disease) with
evidence of metastatic disease and present or past histological documentation of
adenocarcinoma of the colon or rectum.
- Tumor must be measureable.
- Resolution of all acute toxic effects of any prior radiotherapy or surgical procedure.
- ECOG performance status 0 or 1. Age >= 18 years.
- Required baseline laboratory.
- Negative pregnancy test.
- Willingness and ability to comply with the treatment plan.
- Current enrollment in another clinical trial.
- Prior adjuvant therapy for colorectal cancer
- Prior systemic anticancer therapy or intra-arterial cytotoxic chemotherapy given as
treatment for metastatic colorectal cancer.
- Known allergy to CPT-11, 5-FU, LV, celecoxib, other COX-2 inhibitors, non-steroidal
anti-inflammatory drugs (NSAIDS), salicylates, or sulfonamides.
- Chronic concomitant use of full-dose aspirin, other NSAIDs or other COX-2 inhibitors
for a chronic nonmalignant condition.
- A requirement for chronic concomitant use of low-dose (cardioprotective) aspirin.
- Chronic oral steroid use for treatment of a non-malignant condition.
- Known ulceration of the gastric or duodenal mucosa
- Need for concomitant fluconazole or lithium.
- Any known significant bleeding disorder.
- Active inflammatory bowel disease or chronic diarrhea.