Head and Neck Cancer Clinical Trial
Official title:
A Phase II Study of Radiotherapy (IMRT) + Cisplatin + Bevacizumab for Patients With Stage III/IV Head and Neck Cancers
RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the
growth of tumor cells, either by killing the cells or by stopping them from dividing.
Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some
block the ability of tumor cells to grow and spread. Others find tumor cells and help kill
them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of head
and neck cancer by blocking blood flow to the tumor. Specialized radiation therapy that
delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause
less damage to normal tissue. Giving cisplatin and bevacizumab together with
intensity-modulated radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well giving cisplatin and
bevacizumab together with intensity-modulated radiation therapy works in treating patients
with stage III or stage IV head and neck cancer.
Status | Completed |
Enrollment | 44 |
Est. completion date | July 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Stage III/IV HNSCC without distant metastasis, previously untreated. 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 = 55 ml/min by Cockcroft and Gault equation (or 24-hour urine collection). - Age = 18 years - Karnofsky performance status =70% - Adequate bone marrow function: absolute neutrophil count = 1,500/µl, platelets = 100,000/µl, hemoglobin = 9 gm/dl - Adequate hepatic function: Total bilirubin = 1.5 X UNL (patients with Gilbert's syndrome as the cause of hyperbilirubinemia may be eligible if total bilirubin = 2.5 X UNL), aspartate aminotransferase (AST) = 2.5 X UNL, alanine aminotransferase (ALT) = 2.5 X UNL, alkaline phosphatase = 2.5 X UNL. - 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 chemotherapy or radiation therapy for HNSCC - Prior treatment with bevacizumab or other agents specifically targeting VEGF - 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 clinical 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). - History of arterial thromboembolic events, including transient ischemic attack (TIA), cerebrovascular accident (CVA), unstable angina, or myocardial infarction (MI) within the last 3 years. - Urine protein: creatinine (UPC) ratio = 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 (UNL), - Current use of warfarin, current use of heparin or low-molecular weight heparin, chronic daily treatment with aspirin (> 325 mg/day) or nonsteroidal antiinflammatory medications known to inhibit platelet function. Treatment with dipyramidole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix) and or cilostazol (Pletal) is not allowed. - Patients with gross hemoptysis or hematemesis (defined as bright red blood of 1 teaspoon of more) within 1 month prior to Day 1 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 15 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 | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center | Genentech, Inc., National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free survival at 2 years | 2 years | No | |
Secondary | Median overall survival | 2 years | No |
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