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Phase II Trial of Bevacizumab, Cetuximab, and Cisplatin With IMRT (Intensity-Modulated Radiation Therapy) for Patients With Stage III/IV Head and Neck Squamous Cell Carcinoma

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

Thank you

Trial Information

Phase II Trial of Bevacizumab, Cetuximab, and Cisplatin With IMRT (Intensity-Modulated Radiation Therapy) for Patients With Stage III/IV Head and Neck Squamous Cell Carcinoma

Inclusion Criteria:

- Stage III/IV HNSCC without distant metastasis. Patients with stage II squamous cell
carcinoma of the hypopharynx will also be eligible

- Adequate renal function, with serum creatinine ≤ 1.5 mg/dL. Patients with serum
creatinine > 1.5 mg/dL may be eligible if calculated creatinine clearance > or = to
55 ml/min by Cockcroft and Gault equation (or 24-hour urine collection).

- Age > or = to 18 years.

- Karnofsky performance status > or = to 70%

- Adequate bone marrow function: absolute neutrophil count > or = to 1,500/ platelets
> or = to 100,000/ul, hemoglobin > or = to 9 gm/dl

- Adequate hepatic function: Total bilirubin ≤ 1.5 X ULN (patients with Gilbert's
syndrome as the cause of hyperbilirubinemia may be eligible if total bilirubin ≤ 2.5
X ULN), aspartate aminotransferase (AST) ≤ 2.5 X ULN, alanine aminotransferase (ALT)
≤ 2.5 X ULN, alkaline phosphatase ≤ 2.5 X ULN.

- Men and women of childbearing potential must be willing to consent to using effective
contraception while on treatment and for at least 3 months thereafter.

- Patients must have ability to understand and the willingness to sign a written
informed consent document.

Exclusion Criteria:

- Prior radiation therapy for HNSCC

- Prior treatment of HNSCC with bevacizumab or other agents specifically targeting VEGF

- Prior treatment of HNSCC with cetuximab or other agents specifically targeting EGFR

- Other active malignancy, other than indolent malignancies, which the investigator
determines are unlikely to interfere with treatment or efficacy analysis. For
example, patients with non-melanoma skin cancer, in situ carcinoma of the cervix, or
prostate cancer within the no current biochemical (PSA) or radiologic evidence of
disease may enroll.

- Patients with nasopharyngeal carcinoma

- Patients who will receive amifostine as part of the radiation treatment plan

- Patients with skin breakdown/ulceration (CTCAE version 3.0, grade 2 or higher).

- Patients with hearing loss requiring hearing aid or intervention (i.e. interfering in
a clinically significant way with activities of daily living).

- Patients with multifocal peripheral sensory alterations or paresthesias (including
tingling) interfering with function, per patient report (example: activities of daily

- Any prior documented history of transient ischemic attack (TIA) or cerebrovascular
accident (CVA)

- History of unstable angina or myocardial infarction (MI) within the last year.

- Urine protein: creatinine (UPC) ratio > or = to 1.0 at screening. A random urine
sample is collected. Total protein (mg/dL) and spot creatinine (mg/dL) are ordered
for this sample. The UPC ratio is calculated from the results of these tests.

- International normalized ratio (INR) > 1.5 or activated partial thromboplastin time
(aPTT) > 1.5 X upper limits of normal (ULN)

- Current use of warfarin, current use of heparin or low-molecular weight heparin,
chronic daily treatment with aspirin (> 325 mg/day) or nonsteroidal anti-inflammatory
medications known to inhibit platelet function.

- Patients with gross hemoptysis or hematemesis (defined as bright red blood of 1
teaspoon of more) within 28 days prior to Day 0 protocol treatment will be excluded
from this trial. Patients with incidental blood mixed with phlegm are not excluded.

- Esophageal varices, non-healing ulcer, wound, or bone fracture are exclusion
criteria. However, patients with skin breakdown overlying malignant neck
lymphadenopathy may be eligible, at the discretion of the investigator.

- Anatomic lesion that increases the risk of serious hemorrhage, such as encasement or
invasion of major blood vessels by primary tumor and/or by involved lymph nodes

- Blood pressure of > 150/100 mmHg

- New York Heart Association (NYHA) Grade II or greater congestive heart failure.

- Clinically significant peripheral vascular disease

- History of bleeding diathesis or hemorrhagic disorder, or coagulopathy.

- Major surgical procedure or significant traumatic injury within 28 days prior to
treatment with bevacizumab

- Core biopsy within 7 days prior to treatment with bevacizumab.

- Minor surgical procedures such as fine needle aspirations or placement of
percutaneous gastrostomy tube (PEG) less than 7 days prior to treatment with

- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months prior enrollment.

- Inability to comply with study and/or follow-up procedures

- Women who are pregnant or lactating

Type of Study:


Study Design:

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

Outcome Measure:

To determine the 2-year progression-free survival for patients with locally or regionally advanced HNSCC treated with concurrent IMRT + cisplatin + bevacizumab + cetuximab.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Matthew Fury, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

August 2009

Completion Date:

August 2014

Related Keywords:

  • Head and Neck Cancer
  • bevacizumab
  • cisplatin
  • cetuximab
  • radiation therapy
  • Phase II
  • 09-083
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms



Memorial Sloan Kettering Cancer Center New York, New York  10021
Memorial Sloan-Kettering Cancer Center at Basking Ridge Basking Ridge, New Jersey  07920
Memorial Sloan-Kettering Cancer Center at Commack Commack, New York  11725
Memorial Sloan-Kettering Cancer Center at Mercy Medical Center Rockville Centre, New York  11570
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center Sleepy Hollow, New York  10591