Head and Neck Cancer Clinical Trial
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
NCT number | NCT00968435 |
Other study ID # | 09-083 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | August 28, 2009 |
Last updated | August 9, 2016 |
Start date | August 2009 |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan Kettering Cancer Center at Basking Ridge | Basking Ridge | New Jersey |
United States | Memorial Sloan Kettering Cancer Center at Commack | Commack | New York |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
United States | Memorial Sloan Kettering Cancer Center at Mercy Medical Center | Rockville Centre | New York |
United States | Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center | Sleepy Hollow | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center | Genentech, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the 2-year progression-free survival for patients with locally or regionally advanced HNSCC treated with concurrent IMRT + cisplatin + bevacizumab + cetuximab. | 2 years | No | |
Secondary | To determine median overall survival for patients with locally or regionally advanced HNSCC treated with concurrent IMRT + cisplatin + bevacizumab + cetuximab. | 2 years | No | |
Secondary | To evaluate the safety and tolerability of concurrent IMRT + cisplatin + bevacizumab + cetuximab. | 2 years | Yes | |
Secondary | To explore the potential utility of 18F FLT PET for early response assessment. | 2 years | No |
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