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Cisplatin, Bevacizumab, and Intensity-Modulated Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00423930
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Drug: bevacizumab
Drug: cisplatin
Procedure: conventional surgery
Procedure: intensity-modulated radiation therapy
Phase II

MedlinePlus related topics: Cancer Head and Neck Cancer
Drug Information available for: Cisplatin Bevacizumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study of Radiotherapy (IMRT) + Cisplatin + Bevacizumab for Patients With Stage III/IV Head and Neck Cancers

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival at 2 years [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Median overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: October 2006
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the 2-year progression-free survival of patients with stage III or IV squamous cell carcinoma of the head and neck treated with chemoradiotherapy comprising cisplatin, bevacizumab, and intensity-modulated radiotherapy.
  • Determine the safety and tolerability of this regimen in these patients.

Secondary

  • Determine the median overall survival of patients treated with this regimen.

OUTLINE:

  • Chemoradiotherapy: Patients receive cisplatin IV over 1 hour on days 1, 2, 22, 23, 43, and 44 and bevacizumab IV over 30-90 minutes on days 1, 22, and 43. Patients also undergo intensity-modulated radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47. Treatment continues in the absence of disease progression or unacceptable toxicity.

Between 3-4 months after completion of chemoradiotherapy, patients undergo evaluation. Patients with clinical evidence of residual, progressive, or persistent disease may be eligible to undergo neck surgery at the discretion of their physician.

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed squamous cell carcinoma of the head and neck

    • Stage III or IV disease

      • Stage II squamous cell carcinoma of the hypopharynx allowed
  • No distant metastases
  • No nasopharyngeal carcinoma

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 70-100%
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9 g/dL
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN) (≤ 2.5 times ULN for patients with Gilbert's syndrome)
  • AST and ALT ≤ 1.5 times ULN
  • Alkaline phosphatase ≤ 1.5 times ULN
  • INR ≤ 1.5 OR aPTT ≤ 1.5 times ULN
  • Creatinine clearance ≥ 55 mL/min
  • Urine protein:creatinine ratio < 1.0
  • Blood pressure ≤ 150/100 mm Hg
  • No arterial thromboembolic events within the past 3 years, including any of the following:

    • Transient ischemic attack
    • Cerebrovascular accident
    • Unstable angina
    • Myocardial infarction
  • No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
  • No other active malignancy except indolent malignancies that are unlikely to interfere with treatment or efficacy analysis, including any of the following:

    • Carcinoma in situ of the cervix
    • Nonmelanoma skin cancer
    • Prostate cancer without current biochemical or radiologic evidence of disease
  • No anatomic lesion that increases the risk of serious hemorrhage (e.g., encasement or invasion of major blood vessels by primary tumor and/or by involved lymph nodes)
  • No gross hemoptysis or hematemesis, defined as ≥ 1 teaspoon of bright red blood, within the past 28 days

    • Incidental blood mixed with phlegm allowed
  • No skin breakdown or ulceration

    • Skin breakdown overlying malignant neck lymphadenopathy may be allowed
  • No hearing deficit requiring hearing aid or intervention
  • No significant traumatic injury within the past 28 days
  • No New York Heart Association class II-IV congestive heart failure
  • No history of bleeding diathesis, hemorrhagic disorder, or coagulopathy
  • No nonhealing ulcer, bone fracture, or wound
  • No clinically significant peripheral vascular disease
  • No peripheral neuropathy (multifocal) interfering with function
  • No concurrent esophageal varices
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment

PRIOR CONCURRENT THERAPY:

  • More than 7 days since prior minor surgical procedures (e.g., fine-needle biopsy or percutaneous gastrostomy tube placement)
  • More than 28 days since prior major surgical procedure (15 days for core biopsy)
  • No prior chemotherapy or radiotherapy for this cancer
  • No prior bevacizumab or other vascular endothelial growth factor targeting agents
  • No concurrent chronic daily nonsteroidal anti-inflammatory medications known to inhibit platelet function
  • No concurrent chronic daily treatment with aspirin (> 325 mg/day)
  • No concurrent warfarin, heparin, or low-molecular weight heparin
  • No concurrent amifostine as part of radiation treatment
  • No concurrent administration of any of the following:

    • Dipyridamole
    • Ticlopidine
    • Clopidogrel bisulfate
    • Cilostazol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00423930

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: David G. Pfister, MD     212-639-8235        
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: David G. Pfister, MD Memorial Sloan-Kettering Cancer Center
Investigator: Matthew G. Fury, MD, PhD Memorial Sloan-Kettering Cancer Center
Investigator: Nancy Lee, MD Memorial Sloan-Kettering Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Responsible Party: Memorial Sloan-Kettering Cancer Center ( David G. Pfister )
Study ID Numbers: CDR0000518599, MSKCC-06130, PFIZER-MSKCC-06130
Study First Received: January 16, 2007
Last Updated: December 16, 2008
ClinicalTrials.gov Identifier: NCT00423930  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage II squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the larynx
stage III squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity
stage III squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx
stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity

Study placed in the following topic categories:
Epidermoid carcinoma
Cisplatin
Squamous cell carcinoma
Head and Neck Neoplasms
Carcinoma, squamous cell
Laryngeal carcinoma
Hypopharyngeal cancer
Bevacizumab
Carcinoma, Squamous Cell
Dental Caries
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Antineoplastic Agents
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009