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

Memorial Sloan Kettering Cancer Center (MSK) logo

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase

Completed
Phase 2

Conditions

Head and Neck Cancer

Treatments

Other: bevacizumab, cisplatin, cetuximab, radiation therapy

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00968435
09-083

Details and patient eligibility

About

The purpose of this study is to determine the effectiveness of treatment with bevacizumab + cisplatin + cetuximab + IMRT. The doctor wishes to monitor patients for 2 years after the completion of study treatment to determine if they are cancer-free during that time. They also want to evaluate the side effects that patients experience with this treatment regimen.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 living). * 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 bevacizumab * 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

(IMRT) + cisplatin + bevacizumab + cetuximab
Experimental group
Description:
This is a single-institution, non-randomized, phase II study. The primary endpoint is to determine 2-year progression-free survival for patients with locally or regionally advanced HNSCC treated with concurrent intensity modulated radiation therapy (IMRT) + cisplatin + bevacizumab + cetuximab.
Treatment:
Other: bevacizumab, cisplatin, cetuximab, radiation therapy

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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