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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00588770 |
RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, 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 make tumor cells more sensitive to chemotherapy and stop the growth of head and neck cancer by blocking blood flow to the tumor. It is not yet known whether combination chemotherapy is more effective when given with or without bevacizumab in treating patients with head and neck cancer.
PURPOSE: This randomized phase III trial is studying chemotherapy to see how well it works with or without bevacizumab in treating patients with recurrent or metastatic head and neck cancer.
Condition | Intervention | Phase |
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Head and Neck Cancer |
Biological: bevacizumab Drug: cisplatin Drug: docetaxel Drug: fluorouracil |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
Official Title: | A Phase III Randomized Trial of Chemotherapy With or Without Bevacizumab In Patients With Recurrent Or Metastatic Head and Neck Cancer |
Estimated Enrollment: | 400 |
Study Start Date: | August 2008 |
Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Active Comparator
Patients receive chemotherapy comprising docetaxel IV over 1 hour and cisplatin IV over 1-2 hours on day 1 OR cisplatin IV over 1-2 hours on day 1 and fluorouracil IV continuously over days 1-4. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
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Drug: cisplatin
IV
Drug: docetaxel
IV
Drug: fluorouracil
IV
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Arm II: Experimental
Patients receive chemotherapy as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment with chemotherapy and bevacizumab repeats every 21 days in the absence of disease progression or unacceptable toxicity.
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Biological: bevacizumab
IV
Drug: cisplatin
IV
Drug: docetaxel
IV
Drug: fluorouracil
IV
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified by performance status (0 vs 1), weight loss (< 5% vs ≥ 5% of total body weight in the past 6 months), prior radiotherapy to head and neck (yes vs no), and chemotherapy regimen (cisplatin/docetaxel vs cisplatin/fluorouracil). Patients are randomized to 1 of 2 treatment arms.
NOTE: *Treatment with chemotherapy may be discontinued if there is maximum response (i.e., no improvement in tumor measurements for 2 or more courses) after course 6; bevacizumab administration continues until disease progression in arm II.
After completion of study treatment, patients are followed every 3-6 months for 5 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (SCCHN) from any primary site
Patients must have measurable disease based on RECIST
Patients must be progression-free for at least 6 months after completion of chemotherapy or chemoradiotherapy or radiotherapy plus cetuximab given as part of initial potential curative therapy (if received such prior therapy)
PATIENT CHARACTERISTICS:
AST or ALT and alkaline phosphatase must meet one of the following criteria:
Patients who meet the following criteria are excluded:
Patients with a prior history of squamous cell or basal cell carcinoma of the skin or in situ carcinoma of the cervix must have been curatively treated
Patients must have a blood pressure (BP) ≤ 150/90 within 2 weeks prior to randomization
PRIOR CONCURRENT THERAPY:
No more than one prior radiotherapy regimen, curative or palliative, to the head and neck allowed
No prior chemotherapy or biologic/molecular-targeted therapy for recurrent or metastatic SCCHN
Patients may have received one regimen of induction, concurrent chemoradiotherapy, and/or adjuvant chemotherapy as part of initial potential curative therapy
Patients must not be receiving chronic daily treatment with aspirin (> 325 mg/day) or nonsteroidal anti-inflammatory agents (NSAIDs) known to inhibit platelet function
Study Chair: | Athanassios Argiris, MD | UPMC Cancer Centers |
Investigator: | Panos Savvides, MD | Case Comprehensive Cancer Center |
Responsible Party: | ECOG Group Chair's Office ( Robert L. Comis ) |
Study ID Numbers: | CDR0000582533, ECOG-E1305 |
Study First Received: | December 28, 2007 |
Last Updated: | May 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00588770 History of Changes |
Health Authority: | Unspecified |
recurrent squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the larynx stage IV verrucous carcinoma of the larynx recurrent squamous cell carcinoma of the larynx recurrent verrucous carcinoma of the larynx recurrent squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the lip and oral cavity recurrent verrucous carcinoma of the oral cavity stage IV verrucous carcinoma of the oral cavity metastatic squamous neck cancer with occult primary squamous cell carcinoma |
recurrent metastatic squamous neck cancer with occult primary untreated metastatic squamous neck cancer with occult primary recurrent squamous cell carcinoma of the nasopharynx stage IV squamous cell carcinoma of the nasopharynx recurrent squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity recurrent salivary gland cancer salivary gland squamous cell carcinoma stage IV salivary gland cancer |
Antimetabolites Nasopharyngeal Carcinoma Immunologic Factors Laryngeal Carcinoma Bevacizumab Squamous Cell Carcinoma Angiogenesis Inhibitors Immunosuppressive Agents Recurrence Carcinoma |
Hypopharyngeal Cancer Docetaxel Cisplatin Metastatic Squamous Neck Cancer With Occult Primary Fluorouracil Head and Neck Neoplasms Epidermoid Carcinoma Carcinoma, Squamous Cell Salivary Gland Diseases |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Bevacizumab Angiogenesis Inhibitors |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Head and Neck Neoplasms Fluorouracil Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |