Bevacizumab, Cetuximab, and Cisplatin With IMRT (Intensity-Modulated Radiation Therapy) for Patients With Stage III/IV Head and Neck Squamous Cell Carcinoma
This trial is active, not recruiting.
|Condition||head and neck cancer|
|Treatment||bevacizumab, cisplatin, cetuximab, radiation therapy|
|Sponsor||Memorial Sloan Kettering Cancer Center|
|Start date||August 2009|
|End date||August 2017|
|Trial size||30 participants|
|Trial identifier||NCT00968435, 09-083|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Basking Ridge, NJ||Memorial Sloan Kettering Cancer Center at Basking Ridge||no longer recruiting|
|Commack, NY||Memorial Sloan Kettering Cancer Center at Commack||no longer recruiting|
|New York, NY||Memorial Sloan Kettering Cancer Center||no longer recruiting|
|Rockville Centre, NY||Memorial Sloan Kettering Cancer Center at Mercy Medical Center||no longer recruiting|
|Sleepy Hollow, NY||Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
To determine the 2-year progression-free survival for patients with locally or regionally advanced HNSCC treated with concurrent IMRT + cisplatin + bevacizumab + cetuximab.
time frame: 2 years
To determine median overall survival for patients with locally or regionally advanced HNSCC treated with concurrent IMRT + cisplatin + bevacizumab + cetuximab.
time frame: 2 years
To evaluate the safety and tolerability of concurrent IMRT + cisplatin + bevacizumab + cetuximab.
time frame: 2 years
To explore the potential utility of 18F FLT PET for early response assessment.
time frame: 2 years
Male or female participants at least 18 years old.
- 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.
- 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
|Official title||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|
|Principal investigator||David Pfister, MD|
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