Cisplatin, Fluorouracil, Cetuximab, and Radiation Therapy in Treating Patients With HIV and Stage I, Stage II, or Stage III Anal Cancer

Trial 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

• Histologically confirmed stage I-IIIB invasive anal canal or perianal (anal margin)
  squamous cell carcinoma, including tumors with any of the following nonkeratinizing
  histologies:
      - Basoloid
      - Transitional cell
      - Cloacogenic
• Documented HIV infection by 1 of the following:
      - Antibody detection
      - Culture
      - Quantitative assay of plasma HIV RNA

• 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

• No prior chemotherapy or radiotherapy for this malignancy
      - Prior radiotherapy for another condition (e.g., Kaposi's sarcoma) allowed

Detailed Description

• 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.

• 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.

Final eligibility is determined by the health professionals conducting the trial and the protocol approved by the Committee on Human Resources (CHR) at the University of California, San Francisco (UCSF). The Patient Consent Form for this trial is available upon request. For more information about this trial, please see the full posting at ClinicalTrials.gov.

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