CompletedPhase 2

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

United States46 participantsStarted 2006-12-13

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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…

What they're measuring

Percentage of Patients With a Grade 4 Hemorrhage or Any Grade 5 Adverse Event Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment During the First Year.

Timeframe: From start of treatment to one year.

Trial details

NCT IDNCT00408694

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2011-12-15

Results submitted2013-03-01