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Brief Title: Combined Modality Therapy for Patients With With HIV and Stage I, Stage II, or Stage III Anal Cancer
Official Title: Phase II Trial of Combined Modality Therapy Plus Cetuximab in HIV-Associated Anal Carcinoma
Study ID: NCT00324415
Brief 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.
Detailed Description: OBJECTIVES: Primary * 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. Secondary * 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Rebecca and John Moores UCSD Cancer Center, La Jolla, California, United States
UCLA Clinical AIDS Research and Education (CARE) Center, Los Angeles, California, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis, Saint Louis, Missouri, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine, Bronx, New York, United States
Joan Karnell Cancer Center at Pennsylvania Hospital, Philadelphia, Pennsylvania, United States
Benaroya Research Institute at Virginia Mason Medical Center, Seattle, Washington, United States
Name: Joseph A. Sparano, MD
Affiliation: Albert Einstein College of Medicine
Role: STUDY_CHAIR
Name: Lisa A. Kachnic, MD
Affiliation: Massachusetts General Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: David M. Aboulafia, MD
Affiliation: Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center
Role: PRINCIPAL_INVESTIGATOR