This is a phase II trial of combined modality therapy (CMT) consisting of cisplatin, 5-FU and irradiation plus cetuximab. This trial is designed to detect whether the addition of cetuximab to standard chemo-radiation reduces the failure rate of treatment. All participants will receive CMT with 2 cycles of cisplatin and 5-FU chemotherapy, given at the same time as radiation therapy.

Subjects will be followed for up to 5 years.

Inclusion Criteria:

• Men and women 18 years or older
• Biopsy proven stage I to IIIB invasive anal canal or perianal squamous cell cancer
• Laboratory tests within safety levels 14 days of study entry

Exclusion criteria:

• Acute active serious uncontrolled opportunistic infection
• A CD4 count below 50 if in conjunction with an opportunistic infection within the past 6 months
• Prior invasive cancer diagnosed within the last 2 years, excluding in situ cervical cancer, anal dysplasia or cancer in situ, non-melanoma cancer, or Kaposi's sarcoma that has not required chemotherapy within the past 2 years
• Grade 2, 3, or 4 neuropathy
• Severe or poorly controlled diarrhea
• Known pregnancy or breast feeding

This study is being conducted by Dr. Ronald Mitsuyasu under IRB #06-05-094-01

If you think you might be interested in participating in this study, please contact Blanca Corea at 310-557-9062 or email at bcorea@mednet.ucla.edu

Return to Clinical Trials main page