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
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.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Local failure rate at 3 years
3 years following treatment discontinuation
Joseph A. Sparano, MD
Albert Einstein College of Medicine of Yeshiva University
United States: Institutional Review Board
|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|