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Phase II Trial of Combined Modality Therapy Plus Cetuximab in HIV-Associated Anal Carcinoma

Phase 2
18 Years
Open (Enrolling)
Anal Cancer

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Trial Information

Phase II Trial of Combined Modality Therapy Plus Cetuximab in HIV-Associated Anal Carcinoma



- 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.

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.

Inclusion Criteria


- Histologically confirmed stage I-IIIB invasive anal canal or perianal (anal margin)
squamous cell carcinoma, including tumors with any of the following nonkeratinizing

- Basaloid

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Local failure rate at 3 years

Outcome Time Frame:

3 years following treatment discontinuation

Safety Issue:


Principal Investigator

Joseph A. Sparano, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Albert Einstein College of Medicine of Yeshiva University


United States: Institutional Review Board

Study ID:




Start Date:

September 2006

Completion Date:

April 2016

Related Keywords:

  • Anal Cancer
  • 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
  • Anus Neoplasms



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Rebecca and John Moores UCSD Cancer Center La Jolla, California  92093-0658
Albert Einstein Cancer Center at Albert Einstein College of Medicine Bronx, New York  10461
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis St. Louis, Missouri  63110
Joan Karnell Cancer Center at Pennsylvania Hospital Philadelphia, Pennsylvania  19107
UCLA Clinical AIDS Research and Education (CARE) Center Los Angeles, California  90024
Benaroya Research Institute at Virginia Mason Medical Center Seattle, Washington  98101