Study:
A Phase III Randomized Trial of Chemotherapy With or Without Bevacizumab In Patients With Recurrent Or Metastatic Head and Neck Cancer
Rationale:
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 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.
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 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.
Study Status: Recruiting
Recruiting:
Bruno R. Bastos 954-659-5705
| Condition |
Intervention |
Phase |
Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
Recurrent Metastatic Squamous Neck Cancer With Occult Primary
Recurrent Salivary Gland Cancer
Recurrent Squamous Cell Carcinoma of the Hypopharynx
Recurrent Squamous Cell Carcinoma of the Larynx
Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
Recurrent Squamous Cell Carcinoma of the Nasopharynx
Recurrent Squamous Cell Carcinoma of the Oropharynx
Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
Recurrent Verrucous Carcinoma of the Larynx
Recurrent Verrucous Carcinoma of the Oral Cavity
Salivary Gland Squamous Cell Carcinoma
Stage IV Salivary Gland Cancer
Stage IV Squamous Cell Carcinoma of the Hypopharynx
Stage IV Squamous Cell Carcinoma of the Larynx
Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage IV Squamous Cell Carcinoma of the Nasopharynx
Stage IV Squamous Cell Carcinoma of the Oropharynx
Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
Stage IV Verrucous Carcinoma of the Larynx
Stage IV Verrucous Carcinoma of the Oral Cavity
Tongue Cancer
Untreated Metastatic Squamous Neck Cancer With Occult Primary |
Drug: docetaxel
Drug: cisplatin
Drug: carboplatin
Drug: fluorouracil
Biological: bevacizumab |
Phase 3 |
Verified by
National Cancer Institute (NCI)
March, 2013
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov identifier: NCT00588770
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic Florida - Weston
Weston, Florida 33331
United States
Athanassios Argiris., Principal Investigator