Radiation Therapy, Cisplatin, Fluorouracil, and Cetuximab in Treating Patients With Locally Advanced Anal Cancer

DISEASE CHARACTERISTICS:

• Histologically confirmed anal cancer

  • Squamous cell disease
  • Locally advanced, non-metastatic disease

  • One of the following clinical TNM stages:

    • T2, N0, M0 (largest diameter ≥ 3 cm)
    • T3-T4, N0, M0
    • Any T, N1-N3, M0
• No undifferentiated small cell carcinoma or adenocarcinoma
• Measurable disease according to RECIST criteria
• Undergone endorectal ultrasound or MRI to evaluate the primary tumor
• Undergone thoraco-abdomino-pelvic scan to evaluate tumor extension
• Disease suitable to receive radiotherapy and chemotherapy

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1
• Leukocytes ≥ 4,000/mm^3
• ANC ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 10 g/dL
• Creatinine clearance > 60 mL/min
• ALT and AST ≤ 5 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 2.5 times ULN
• Total bilirubin ≤ 1.5 times ULN
• Not pregnant or nursing
• Negative pregnancy test
• No history of cancer within the past 8 years except for in situ cervical cancer or previously treated basal cell carcinoma of the skin
• No contraindications to any component of study therapy
• No serious uncontrolled illness
• No symptomatic grade 1 angina pectoris or angina pectoris ≥ grade 2
• No congestive heart failure
• No peripheral sensory neuropathy
• No uncontrolled diabetes
• No HIV positivity
• No geographical, social, or psychological situations that preclude medical follow up
• Affiliated with a social security system
• No patient deprived of liberty or under trusteeship

PRIOR CONCURRENT THERAPY:

• Patients with a diverting colostomy are eligible
• No prior excision of this tumor
• No prior chemotherapy or radiotherapy for the treatment of this cancer or any other history of radiotherapy or pelvic brachytherapy
• No concurrent coumarin anticoagulants, phenytoin, sorivudine or brivudine, antacids, or allopurinol
• Not registered in another clinical trial with an experimental drug