Bevacizumab, Cisplatin, Radiation Therapy, and Fluorouracil in Treating Patients With Stage IIB, Stage III, Stage IVA, or Stage IVB Nasopharyngeal Cancer

Completed · Phase 2

Conditions studied: Stage II Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7, Stage III Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7, Stage III Nasopharyngeal Undifferentiated Carcinoma AJCC v7, Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7, Stage IV Nasopharyngeal Undifferentiated Carcinoma AJCC v7

In brief

This phase II trial is studying how well giving bevacizumab together with cisplatin, radiation therapy, and fluorouracil works in treating patients with stage IIB, stage III, stage IVA, or stage IVB nasopharyngeal cancer. Monoclonal antibodies, such as bevacizumab, 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. Bevacizumab may also stop the growth of nasopharyngeal cancer by blocking blood flow to the tumor. 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving bevacizumab together with chemotherapy and radiation therapy may kill more tumor cells.

Key facts

Study ID

NCT00408694

Run by

National Cancer Institute (NCI)

People needed

46

Starts

2006-12-13

Expected to finish

2011-12-15

Last updated by the study team

2018-01-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed cancer of the nasopharynx based on biopsy of a primary lesion and/or lymph nodes
• Histologic WHO types I-IIb/III
• Stage IIB-IVB disease
• No T1-2, N1 disease in which node positivity is based on the presence of retropharyngeal lymph nodes
• No distant metastases
• Zubrod performance status 0-1
• WBC ? 4,000/mm?
• Hemoglobin ? 9.0 g/dL
• Platelet count ? 100,000/mm?
• Absolute neutrophil count ? 1,500/mm?
• INR ? 1.5
• aPTT ? 1.5 times upper limit of normal (ULN)
• Alkaline phosphatase ? 1.5 times ULN
• ALT and AST ? 1.5 times ULN
• Bilirubin ? 1.5 times ULN
• Creatinine ? 1.5 mg/dL OR creatinine clearance ? 55 mL/min
• Urine protein:creatinine (UPC) ratio < 1.0
• If UPC > 0.5, 24-hour urine protein must be < 1,000 mg
• Hearing loss primarily sensorineural in nature and requiring a hearing aid or intervention that interferes in a clinically significant way with activities of daily living allowed
• Conductive hearing loss from tumor-related otitis media is allowed
• No severe, active comorbidity, including any of the following:
• Ongoing bleeding diathesis, hemorrhagic disorder, or coagulopathy within the past 6 months
• Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
• Esophageal varices, nonhealing wound, nonhealing ulcer, or bone fracture within the past 6 months
• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within the past 30 days

Where it is running

• Sutter Cancer Centers Radiation Oncology Services-Auburn — Auburn, California, United States
• Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California, United States
• Sutter Cancer Centers Radiation Oncology Services-Cameron Park — Cameron Park, California, United States
• Mercy San Juan Medical Center — Carmichael, California, United States
• East Bay Radiation Oncology Center — Castro Valley, California, United States
• Eden Hospital Medical Center — Castro Valley, California, United States
• Valley Medical Oncology Consultants-Castro Valley — Castro Valley, California, United States
• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• Bay Area Breast Surgeons Inc — Emeryville, California, United States
• Valley Medical Oncology Consultants-Fremont — Fremont, California, United States
• Contra Costa Regional Medical Center — Martinez, California, United States
• Highland General Hospital — Oakland, California, United States
• Alta Bates Summit Medical Center - Summit Campus — Oakland, California, United States
• Bay Area Tumor Institute — Oakland, California, United States
• Hematology and Oncology Associates-Oakland — Oakland, California, United States
• Tom K Lee Inc — Oakland, California, United States
• Stanford Cancer Institute Palo Alto — Palo Alto, California, United States
• Valley Care Health System - Pleasanton — Pleasanton, California, United States
• Valley Medical Oncology Consultants — Pleasanton, California, United States
• Sutter Cancer Centers Radiation Oncology Services-Roseville — Roseville, California, United States
• Sutter Medical Center Sacramento — Sacramento, California, United States
• Mercy General Hospital Radiation Oncology Center — Sacramento, California, United States
• Doctors Medical Center- JC Robinson Regional Cancer Center — San Pablo, California, United States
• Sutter Cancer Centers Radiation Oncology Services-Vacaville — Vacaville, California, United States
• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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