Status:
COMPLETED
Bevacizumab, Cisplatin, Radiation Therapy, and Fluorouracil in Treating Patients With Stage IIB, Stage III, Stage IVA, or Stage IVB Nasopharyngeal Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Collaborating Sponsors:
Radiation Therapy Oncology Group
Conditions:
Stage II Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7
Stage III Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 n...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the safety and tolerability of bevacizumab and chemoradiotherapy comprising cisplatin and radiotherapy followed by adjuvant therapy comprising cisplatin, fluorouracil...
Eligibility Criteria
Inclusion
- 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 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 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 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
Exclusion
Key Trial Info
Start Date :
December 13 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2011
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00408694
Start Date
December 13 2006
End Date
December 15 2011
Last Update
January 30 2018
Active Locations (108)
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1
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
2
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, United States, 95603
3
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States, 91505
4
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, United States, 95682