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Clinical Trial Summary

This randomized phase III trial studies chemotherapy to see how well it works with or without bevacizumab in treating patients with head and neck squamous cell carcinoma that has come back (recurrent) or that has spread to other parts of the body (metastatic). Drugs used in chemotherapy, such as docetaxel, cisplatin, carboplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. 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 squamous cell carcinoma.


Clinical Trial Description

PRIMARY OBJECTIVES: I. To compare the overall survival of patients with recurrent or metastatic head and neck cancer treated with standard platinum-based chemotherapy with or without bevacizumab. SECONDARY OBJECTIVES: I. To assess toxicities with the addition of bevacizumab to each platinum-doublet (cisplatin/docetaxel, carboplatin/docetaxel, cisplatin/fluorouracil [5-FU], carboplatin/5-FU). II. To compare the objective response rates and the progression-free survival achieved with the above therapies. III. To collect blood samples before and after therapy for future correlative studies. IV. To collect tumor tissue samples available at baseline from prior diagnostic procedures for future correlative studies. OUTLINE: After the physician decides which chemotherapy doublet to use, patients are randomized to 1 of 2 treatment arms for that chemotherapy combination. ARM IA: Patients receive chemotherapy comprising docetaxel intravenously (IV) over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IB: Patients receive bevacizumab IV over 30-90 minutes on day 1 and docetaxel and cisplatin as in Arm IA. ARM IIA: Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IIB: Patients receive bevacizumab as in arm IB and docetaxel and carboplatin as in Arm IIA. ARM IIIA: Patients receive cisplatin IV over 1-2 hours on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IIIB: Patients receive bevacizumab as in Arm IB and cisplatin and fluorouracil as in Arm IIIA. ARM IVA: Patients receive carboplatin IV over 30 minutes on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IVB: Patients receive bevacizumab as in Arm IB and carboplatin and fluorouracil as in Arm IVA. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years. ;


Study Design


Related Conditions & MeSH terms

  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Mouth Neoplasms
  • Neck Squamous Cell Carcinoma of Unknown Primary
  • Neoplasms, Unknown Primary
  • Recurrence
  • Recurrent Hypopharyngeal Squamous Cell Carcinoma
  • Recurrent Laryngeal Squamous Cell Carcinoma
  • Recurrent Laryngeal Verrucous Carcinoma
  • Recurrent Lip and Oral Cavity Squamous Cell Carcinoma
  • Recurrent Neck Squamous Cell Carcinoma of Unknown Primary
  • Recurrent Oral Cavity Verrucous Carcinoma
  • Recurrent Oropharyngeal Squamous Cell Carcinoma
  • Recurrent Salivary Gland Carcinoma
  • Recurrent Sinonasal Squamous Cell Carcinoma
  • Salivary Gland Neoplasms
  • Salivary Gland Squamous Cell Carcinoma
  • Squamous Cell Carcinoma of Head and Neck
  • Stage IV Hypopharyngeal Squamous Cell Carcinoma AJCC v7
  • Stage IV Major Salivary Gland Cancer AJCC v7
  • Stage IVA Laryngeal Squamous Cell Carcinoma AJCC v7
  • Stage IVA Laryngeal Verrucous Carcinoma AJCC v7
  • Stage IVA Lip and Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
  • Stage IVA Major Salivary Gland Cancer AJCC v7
  • Stage IVA Oral Cavity Cancer AJCC v6 and v7
  • Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7
  • Stage IVA Sinonasal Squamous Cell Carcinoma AJCC v7
  • Stage IVB Laryngeal Squamous Cell Carcinoma AJCC v7
  • Stage IVB Laryngeal Verrucous Carcinoma AJCC v7
  • Stage IVB Lip and Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
  • Stage IVB Major Salivary Gland Cancer AJCC v7
  • Stage IVB Oral Cavity Cancer AJCC v6 and v7
  • Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7
  • Stage IVB Sinonasal Squamous Cell Carcinoma AJCC v7
  • Stage IVC Laryngeal Squamous Cell Carcinoma AJCC v7
  • Stage IVC Laryngeal Verrucous Carcinoma AJCC v7
  • Stage IVC Lip and Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
  • Stage IVC Major Salivary Gland Cancer AJCC v7
  • Stage IVC Oral Cavity Cancer AJCC v6 and v7
  • Stage IVC Oropharyngeal Squamous Cell Carcinoma AJCC v7
  • Stage IVC Sinonasal Squamous Cell Carcinoma AJCC v7
  • Tongue Carcinoma

NCT number NCT00588770
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Active, not recruiting
Phase Phase 3
Start date August 8, 2008
Completion date February 22, 2025

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