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About
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.
Full description
PRIMARY OBJECTIVES:
I. Determine the safety and tolerability of bevacizumab and chemoradiotherapy comprising cisplatin and radiotherapy followed by adjuvant therapy comprising cisplatin, fluorouracil, and bevacizumab in patients with stage IIB-IVB nasopharyngeal cancer.
SECONDARY OBJECTIVES:
I. Determine the 1- and 2-year rates of locoregional progression-free in patients treated with this regimen.
II. Determine the 1- and 2-year rates of distant metastases-free in patients treated with this regimen.
III. Determine the 1- and 2-year rates of progression-free and overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.
ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1 OR days 1 and 2, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
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Inclusion and exclusion criteria
Inclusion Criteria:
Histologically confirmed cancer of the nasopharynx based on biopsy of a primary lesion and/or lymph nodes
Stage IIB-IVB disease
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
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:
No gross hemoptysis or hematemesis, defined as bright red blood of ? 1 teaspoon per coughing episode, within the last 4 weeks (incidental blood mixed with phlegm allowed)
No other invasive malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the breast, oral cavity, or cervix
Nutritional and physical condition considered suitable for study treatment
No significant traumatic injury within the past 4 weeks
No history of allergic reaction to the study drugs
No baseline blood pressure > 150/100 mm Hg
No peripheral neuropathy ? grade 2
Not pregnant or nursing
Negative serum pregnancy test
Fertile patients must use effective contraception during and for ? 6 months after completion of study treatment
At least 10 days since prior and no concurrent dipyridamole, ticlopidine, clopidogrel bisulfate, cilostazol, warfarin, heparin, daily treatment with acetylsalicylic acid (> 325 mg/day), or nonsteroidal anti-inflammatory medications known to inhibit platelet function
No prior head and neck surgery of the primary tumor or lymph nodes except for incisional or excisional biopsies
More than 1 week since prior fine-needle aspirations or placement of percutaneous gastrostomy tube
More than 4 weeks since prior major surgical procedures
No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
No prior bevacizumab or other vascular endothelial growth factor-targeting agents
No prior systemic chemotherapy for the study cancer
No concurrent hematologic growth factors (e.g. filgrastim [G-CSF], darbepoetin alfa, epoetin alfa) during study chemoradiotherapy
No concurrent prophylactic growth factors for neutropenia during study adjuvant therapy
No concurrent prophylactic amifostine or pilocarpine
No other concurrent experimental therapeutic cancer treatments
Primary purpose
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46 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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