Combined Modality Therapy for Patients With With HIV and Stage I, Stage II, or Stage III Anal Cancer
Condition: Anal Cancer
MeSH terms: Anus Neoplasms
Intervention: cetuximab; cisplatin; fluorouracil; radiation therapy
Intervention description: 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); 75 mg/m2 IV on Day 1 (cycle 1) and Day 29 (cycle 2); 1000 mg/m2/day by continuous intravenous infusion on Days 1-4 (cycle 1) and Days 29-32 (cycle 2); 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.
Intervention MeSH terms: Fluorouracil; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage I anal cancer; stage II anal cancer; stage IIIA anal cancer; stage IIIB anal cancer; squamous cell carcinoma of the anus; basaloid carcinoma of the anus; cloacogenic carcinoma of the anus

Summary:

      RATIONALE: Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways.
      Some block the ability of tumor cells to grow and spread. Others find tumor cells and help
      kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy
      x-rays to kill tumor cells. Giving cisplatin, fluorouracil, and cetuximab together with
      radiation therapy may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving cisplatin, fluorouracil, and
      cetuximab together with radiation therapy works in treating patients with HIV and stage I,
      stage II, or stage III anal cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed stage I-IIIB invasive anal canal or perianal (anal margin)
             squamous cell carcinoma, including tumors with any of the following nonkeratinizing
             histologies:

               -  Basaloid

               -  Transitional cell

               -  Cloacogenic

          -  Documented HIV infection by 1 of the following:

               -  Antibody detection

               -  Culture

               -  Quantitative assay of plasma HIV RNA

        PATIENT CHARACTERISTICS:

          -  Karnofsky performance status 60-100%

          -  Absolute neutrophil count ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Hemoglobin ≥ 10 g/dL (transfusions, epoetin alfa, or myeloid growth factor support
             allowed provided blood counts are stable for ≥ 2 weeks prior to study entry)

          -  Creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance > 60 mL/min

          -  AST and ALT ≤ 3 times ULN

          -  Bilirubin ≤ 2 times ULN

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No acute active, serious, uncontrolled opportunistic infection

          -  No other prior invasive malignancy diagnosed within the past 24 months, excluding in
             situ cervical cancer, anal dysplasia or carcinoma in situ, nonmelanoma skin carcinoma,
             or Kaposi's sarcoma that has not required systemic chemotherapy within the past 24
             months

          -  No peripheral neuropathy > grade 1

          -  No severe or poorly controlled diarrhea

          -  No medical or psychiatric illness that would preclude study requirements

        PRIOR CONCURRENT THERAPY:

          -  No prior chemotherapy or radiotherapy for this malignancy

               -  Prior radiotherapy for another condition (e.g., Kaposi's sarcoma) allowed