Celecoxib, Capecitabine, and Irinotecan in Treating Patients With Recurrent or Metastatic Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring adenocarcinoma of the colon, adenocarcinoma of the rectum, recurrent colon cancer, recurrent rectal cancer, stage IV colon cancer, stage IV rectal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the colon or rectum Locally recurrent or metastatic disease Measurable disease, defined as ≥ 1 measurable lesion ≥ 20 mm by conventional CT scan OR ≥ 10 mm by spiral CT scan Bone metastases, ascites, and pleural effusion are not considered measurable disease Measurable lesions must be located outside a previously irradiated field PATIENT CHARACTERISTICS: Performance status SWOG 0-2 Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin normal No Gilbert's disease Renal Creatinine clearance > 50 mL/min Cardiovascular No clinically significant cardiac disease that is not well controlled by medication, including any of the following conditions: Congestive heart failure Symptomatic coronary artery disease Cardiac arrhythmias No myocardial infarction within the past year Gastrointestinal Must have a physically intact upper gastrointestinal tract Able to swallow tablets No history of peptic ulcer disease or gastroesophageal reflux No malabsorption syndrome Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No known HIV positivity No asthma, urticaria, or allergic-type reaction after prior treatment with aspirin or other nonsteroidal anti-inflammatory drugs No other malignancy except curatively treated cancer with no evidence of active disease No unresolved bacterial infection requiring antibiotics No other serious infection No known allergy to study drugs or sulfa drugs PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy for colorectal cancer Patients relapsing > 6 months after completion of prior adjuvant chemotherapy allowed No other concurrent anticancer chemotherapy Endocrine therapy Not specified Radiotherapy See Disease Characteristics At least 3 weeks since prior radiotherapy No concurrent anticancer radiotherapy Surgery Recovered from prior surgery No concurrent anticancer surgery Other Prior celecoxib for nonmalignant disorders allowed No other concurrent cyclooxygenase-2 inhibitors or nonsteroidal anti-inflammatory drugs, including any of the following: Rofecoxib Ibuprofen Naproxen Etodolac Oxaprozin Diflunisal Nabumetone Tolmetin
Sites / Locations
- University of Michigan Comprehensive Cancer Center
- Barbara Ann Karmanos Cancer Institute
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University