Celecoxib, Capecitabine, and Irinotecan in Treating Patients With Recurrent or Metastatic Colorectal Cancer

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