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A Phase II Study of Concurrent Chemoradiotherapy Using Three-Dimensional Conformal Radiotherapy (3D-CRT) or Intensity-Modulated Radiation Therapy (IMRT) + Bevacizumab (BV) for Locally or Regionally Advanced Nasopharyngeal Cancer

Phase 2
18 Years
Open (Enrolling)
Head and Neck Cancer

Thank you

Trial Information

A Phase II Study of Concurrent Chemoradiotherapy Using Three-Dimensional Conformal Radiotherapy (3D-CRT) or Intensity-Modulated Radiation Therapy (IMRT) + Bevacizumab (BV) for Locally or Regionally Advanced Nasopharyngeal Cancer

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/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

- 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


- 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

- No concurrent prophylactic amifostine or pilocarpine

- No other concurrent experimental therapeutic cancer treatments

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety during the first year

Outcome Time Frame:

one year

Safety Issue:


Principal Investigator

Nancy Lee, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

December 2006

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • Head and Neck Neoplasms
  • Nasopharyngeal Neoplasms



University of Medicine and Dentistry of New Jersey Newark, New Jersey  07103-2425