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The purpose of this study is to see how well standard chemotherapy (Cisplatin and 5-Fluorouracil) and Radiation work when combined with Cetuximab in shrinking tumors in patients with HIV-associated anal cancer. Radiation will be given Monday-Friday for approximately 7 weeks. Chemotherapy will be given once a week during this time. Once treatment is complete, you will be asked to return for follow-up visits for up to 5 years.

Basic Inclusion/Exclusion Criteria:
• HIV positive adults who have not received prior chemotherapy or radiation for their anal cancer.
• Stage I-IIIB invasive anal canal or perianal (anal margin) squamous cell carcinoma.
• Adequate hematologic and hepatic function.
• Able and willing to provide written consent
• No acute active, serious, uncontrolled opportunistic infection. Patients with a CD4 count < 50/uL will be excluded if they have had an opportunistic infection within the past 6 months, or if there is evidence of resistance to antiretroviral therapy (i.e., HIV viral load > 400 copies/mL despite antiretroviral therapy).
• No prior invasive malignancy diagnosed within the past 24 months, excluding in situ cervical cancer, anal dysplasia or carcinoma in situ, non-melanoma skin carcinoma, Kaposi’s sarcoma that has not required systemic chemotherapy within the past 24 months.
• No grade 2, 3, or 4 neuropathy.
• No severe (grade 3 or 4) or poorly controlled diarrhea.
• No pregnancy or breast-feeding.
• No medical or psychiatric illness that precludes ability to give informed consent or is likely to interfere with the ability to comply with the protocol.

Study Summary:

Detailed Study Description:

Study Design: Interventional
Phase of Study: Phase II
Study Type: Interventional
Condition or Study Focus: HIV and Anal Cancer
Intervention Type: chemotherapy and radiation
Intervention Name: Cisplatin, 5-Flourouracil, Radiation, Cetuximab
Gender: Male and Female
Age group: Interventional
Sponsor: AIDS Malignancy Consortium (AMC)