Ensayos clínicos

Disease Characteristics:

• Diagnosis of adenocarcinoma of the rectum

  • Clinical stage T3 or T4 disease by endorectal ultrasound or physical examination (for T4 lesions only)
  • Tumor originating at or below 12 cm from the anal verge
  • No extension of disease into the anal canal
• No evidence of distant metastases
• No synchronous primary colon carcinomas except T1 lesions
• Potentially resectable en bloc disease

Patient Characteristics:

• Age
  • 18 and over
• Performance status
  • Zubrod 0-2
• Life expectancy
  • Not specified
• Hematopoietic
  • Absolute neutrophil count > 1,500/mm^3
  • Platelet count > 100,000/mm^3
• Hepatic
  • AST (aspartate aminotransferase) < 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase < 2.5 times ULN
  • Bilirubin ≤ 1.5 times ULN
  • No known uncontrolled coagulopathy
• Renal
  • Creatinine clearance > 50 mL/min
• Cardiovascular
  • No congestive heart failure
  • No symptomatic coronary artery disease
  • No uncontrolled cardiac arrhythmias
  • No myocardial infarction within the past year
  • No other clinically significant cardiac disease
• Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 30 days after completion of study treatment
  • No concurrent serious uncontrolled infection
  • No malabsorption syndrome
  • No lack of physical integrity of the upper gastrointestinal tract
  • No evidence of uncontrolled seizures, central nervous system (CNS) disorders, or psychiatric disability that, judged by the investigator, is clinically significant, precludes giving informed consent, or interferes with compliance of oral drug intake
  • No other malignancy within the past 5 years except nonmelanoma skin cancer, carcinoma in situ of the cervix, or ductal carcinoma in situ of the breast
  • No other serious uncontrolled medical condition that would preclude study participation

Prior Concurrent Therapy:

• Biologic therapy
  • No concurrent routine prophylactic filgrastim (G-CSF)
• Chemotherapy
  • No prior anticancer chemotherapy
• Endocrine therapy
  • Not specified
• Radiotherapy
  • No prior radiotherapy to the pelvis
  • No concurrent intensity-modulated radiotherapy
• Surgery
  • More than 4 weeks since prior major surgery
• Other
  • More than 4 weeks since prior participation in another clinical trial
  • No concurrent cimetidine
  • No concurrent sorivudine or brivudine