• Local failure rate at 3 years [ Time Frame: 3 years following treatment discontinuation ] [ Designated as safety issue: No ]
  

• Progression-free survival [ Time Frame: Up to 5 years following treatment discontinuation ] [ Designated as safety issue: No ]
  
• Relapse-free survival [ Time Frame: Up to 5 years after treatment discontinuation ] [ Designated as safety issue: No ]
  
• Colostomy-free survival [ Time Frame: Up to 5 years following treatment discontinuation ] [ Designated as safety issue: No ]
  
• Overall survival [ Time Frame: Up to 5 years following treatment discontinuation ] [ Designated as safety issue: No ]
  
• Quality of life [ Time Frame: 3 years following treatment discontinuation ] [ Designated as safety issue: No ]
  
• Toxicity [ Time Frame: 90 days following treatment discontinuation ] [ Designated as safety issue: Yes ]
  
• Changes in viral load and CD4 counts during and for 1 year after completion of study treatment [ Time Frame: 1 year following treatment discontinuation ] [ Designated as safety issue: No ]
  
• Incidence of opportunistic illnesses, including the development of AIDS during and for 1 year after completion of study treatment [ Time Frame: 1 year following treatment discontinuation ] [ Designated as safety issue: No ]
  
• Anogenital human papilloma virus (HPV) infection and anal cytology [ Time Frame: 6 months following treatment discontinuation ] [ Designated as safety issue: No ]
  
• Objective response rate (complete and partial) [ Time Frame: 3 years following treatment discontinuation ] [ Designated as safety issue: No ]
  

Biological: cetuximab
400 mg/m2 IV Day -7 (1 week before the cycle 1, Day 1 cisplatin/5-FU and RT), then 250 mg/m2 IV Days 1, 8, 15, 22, 29, 36 and 43 (a minimum of 6 and a maximum of 8 doses of cetuximab will be administered, including the loading dose)
Other Name: Erbitux
Drug: cisplatin
75 mg/m2 IV on Day 1 (cycle 1) and Day 29 (cycle 2)
Other Name: Platinol
Drug: fluorouracil
1000 mg/m2/day by continuous intravenous infusion on Days 1-4 (cycle 1) and Days 29-32 (cycle 2)
Other Names:
• 5-FU
• Adrucil
• Carac
• Efudex
• Fluoroplex
Radiation: radiation therapy
Irradiation to tumor site and inguinal nodes beginning on cycle 1, Day 1 cisplatin/5-FU (minimum 45.0 Gy [5 weeks if given on schedule and without interruption], maximum 54.0 Gy [6 weeks if given on schedule and without interruption). IMRT may be used at the discretion of the treating physician.

OBJECTIVES:

Primary

• Determine the 2-year local failure rate in patients with HIV-associated stage I-IIIB anal carcinoma treated with cisplatin, fluorouracil, cetuximab, and radiotherapy.
• Determine the objective response rate (complete and partial), progression-free survival, relapse-free survival, colostomy-free survival, overall survival, quality of life, and overall toxicity in patients treated with this regimen.

Secondary

• Characterize the effect of this regimen on the underlying HIV condition by describing changes in viral load, CD4 counts, and the incidence of opportunistic illnesses, including the development of AIDS during and in the first year after treatment.
• Evaluate the effect of this regimen on anogenital human papilloma virus (HPV) infection and anal cytology.

OUTLINE: This is an open-label, multicenter study.

Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 35*, fluorouracil IV continuously on days 1-4 and 29-32, and cisplatin IV over 1 hour on days 1 and 29. Beginning on day 1, patients undergo concurrent radiotherapy to the primary tumor 5 days a week for 5-7 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

NOTE: *Patients receiving 7 weeks of radiotherapy also receive cetuximab on days 42 and 49.

Quality of life is assessed at baseline, at the completion of study treatment, and then at months 3, 6, 12, 24, and 36.

After completion of study treatment, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 47 patients will be accrued for this study.