Expired Study
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Newark, New Jersey 07101


Purpose:

The purpose of this study is to determine whether adding bevacizumab to the standard treatment of radiation therapy and chemotherapy is safe and tolerable for participants. This study will find out what effects, good and/or bad, radiation therapy, chemotherapy (cisplatin and 5-fluorouracil) and bevacizumab has on participants and their cancer. The standard treatment for nasopharyngeal cancer is radiation therapy and chemotherapy given together, followed by chemotherapy alone. The standard treatment can stop tumors from growing in the head and neck region in most patients. However, the cancer still can spread to other parts of the body. The study drug, bevacizumab, may decrease the chance of the cancer spreading. Tumors set off the growth of new blood vessels, which feed the tumor. This growth of new blood vessels is called angiogenesis. Bevacizumab is an anti-angiogenic agent, which interrupts the body's ability to grow new blood vessels, causing tumors to shrink. In 2004, the Food and Drug Administration (FDA) approved bevacizumab for treatment of colorectal cancer when used with standard chemotherapy. Bevacizumab is considered investigational (experimental) for the treatment of nasopharyngeal cancer, which means bevacizumab has not been approved by the FDA for the treatment of nasopharyngeal cancer.


Criteria:

S: - 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 PATIENT CHARACTERISTICS: - Zubrod performance status 0-1 - WBC ≥ 4,000/mm³ - Hemoglobin ≥ 9.0 g/dL - Platelet count ≥ 100,000/mm³ - Absolute neutrophil count ≥ 1,500/mm³ - 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 - 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 - Unstable angina and/or congestive heart failure or peripheral vascular disease requiring hospitalization within the past 12 months - Major medical or psychiatric illness that, in the opinion of the study investigator, would preclude study compliance - Active, untreated infection and/or acute bacterial or fungal infection requiring intravenous antibiotics - Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects - History of significant weight loss (> 15% from baseline) - History of arterial thromboembolic events - Acquired immune deficiency syndrome - Transmural myocardial infarction - Cerebrovascular accident - Transient ischemic attack - Any other cardiac condition that, in the opinion of the investigator, would preclude study compliance - No hearing deficit ≥ grade 2 confirmed on baseline audiogram that, in the judgment of the investigator, is felt to have primarily a sensorineural basis (conductive hearing loss from tumor-related otitis media allowed) - 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 pregnancy test - Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment PRIOR CONCURRENT THERAPY: - 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 15 days since prior 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 -Prior chemotherapy for a different cancer allowed - 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


NCT ID:

NCT00707096


Primary Contact:

Principal Investigator
Nancy Lee, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

Newark, New Jersey 07101
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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