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Sponsors and Collaborators: |
AIDS Associated Malignancies Clinical Trials Consortium National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00324415 |
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.
Condition | Intervention | Phase |
Anal Cancer |
Drug: cetuximab Drug: cisplatin Drug: fluorouracil Procedure: radiation therapy |
Phase II |
MedlinePlus related topics: | AIDS Anal Cancer Cancer |
ChemIDplus related topics: | Cisplatin Fluorouracil Cetuximab |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of Combined Modaility Therapy Plus Cetuximab in HIV-Associated Anal Carcinoma |
Estimated Enrollment: | 47 |
Study Start Date: | September 2006 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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*, fluoroucacil 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
Documented HIV infection by 1 of the following:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No prior chemotherapy or radiotherapy for this malignancy
United States, California | |||||
Rebecca and John Moores UCSD Cancer Center | Recruiting | ||||
La Jolla, California, United States, 92093-0658 | |||||
Contact: Clinical Trials Office - Rebecca and John Moores UCSD Cancer 858-822-5354 cancercto@ucsd.edu | |||||
UCLA Clinical AIDS Research and Education (CARE) Center | Recruiting | ||||
Los Angeles, California, United States, 90095-1793 | |||||
Contact: Ronald T. Mitsuyasu, MD 310-206-8359 rmitsuya@mednet.ucla.edu | |||||
United States, Massachusetts | |||||
Beth Israel Deaconess Medical Center | Recruiting | ||||
Boston, Massachusetts, United States, 02215 | |||||
Contact: Clinical Trials Office - Beth Israel Deaconess Medical Center 617-667-9925 | |||||
United States, Missouri | |||||
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Recruiting | ||||
Saint Louis, Missouri, United States, 63110 | |||||
Contact: Lee Ratner, MD, PhD 314-362-8836 lratner@im.wustl.edu | |||||
United States, New York | |||||
Albert Einstein Cancer Center at Albert Einstein College of Medicine | Recruiting | ||||
Bronx, New York, United States, 10461 | |||||
Contact: Clinical Trials Office - Albert Einstein Cancer Center at Albe 718-904-2730 aecc@aecom.yu.edu | |||||
United States, Pennsylvania | |||||
Joan Karnell Cancer Center at Pennsylvania Hospital | Recruiting | ||||
Philadelphia, Pennsylvania, United States, 19106 | |||||
Contact: David H. Henry, MD 215-829-6088 dhhenry@juno.com | |||||
United States, Washington | |||||
Benaroya Research Institute at Virginia Mason Medical Center | Recruiting | ||||
Seattle, Washington, United States, 98101 | |||||
Contact: Clinical Trials Office - Benaroya Research Institute 206-583-6526 |
AIDS Associated Malignancies Clinical Trials Consortium |
National Cancer Institute (NCI) |
Study Chair: | Joseph A. Sparano, MD | Albert Einstein College of Medicine of Yeshiva University |
Investigator: | Lisa A. Kachnic, MD | Massachusetts General Hospital |
Investigator: | David M. Aboulafia, MD | Floyd and Delores Jones Cancer Institute at Virginia Mason Medical Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000440065, AMC-045, AMC-026 |
First Received: | May 10, 2006 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00324415 |
Health Authority: | Unspecified |
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