Cediranib Maleate in Treating Patients With Recurrent or Newly Diagnosed Metastatic Head and Neck Cancer
Completed · Phase 2
Conditions studied: Recurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma, Recurrent Laryngeal Verrucous Carcinoma, Recurrent Lip and Oral Cavity Squamous Cell Carcinoma, Recurrent Metastatic Squamous Cell Carcinoma in the Neck With Occult Primary, Recurrent Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma, Recurrent Nasopharyngeal Keratinizing Squamous Cell Carcinoma, Recurrent Oral Cavity Verrucous Carcinoma, Recurrent Oropharyngeal Squamous Cell Carcinoma, Recurrent Salivary Gland Carcinoma, Salivary Gland Squamous Cell Carcinoma, Squamous Cell Carcinoma Metastatic in the Neck With Occult Primary, Stage IV Hypopharyngeal Squamous Cell Carcinoma, Stage IV Laryngeal Squamous Cell Carcinoma, Stage IV Laryngeal Verrucous Carcinoma, Stage IV Lip and Oral Cavity Squamous Cell Carcinoma, Stage IV Major Salivary Gland Carcinoma, Stage IV Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma, Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma, Stage IV Oral Cavity Verrucous Carcinoma, Stage IV Oropharyngeal Squamous Cell Carcinoma, Tongue Carcinoma, Untreated Metastatic Squamous Cell Carcinoma to Neck With Occult Primary
In brief
This phase II trial is studying how well cediranib maleate works in treating patients with recurrent or newly diagnosed metastatic head and neck cancer. Cediranib maleate may stop the growth of head and neck cancer by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Key facts
- Study ID
- NCT00458978
- Run by
- National Cancer Institute (NCI)
- People needed
- 6
- Starts
- 2007-02-01
- Expected to finish
- 2014-07-01
- Last updated by the study team
- 2015-05-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed squamous cell carcinoma of the head and neck meeting one of the following criteria:
- Recurrent disease
- Previously treated with standard curative therapy, including surgery and/or radiotherapy with or without chemotherapy
- Newly diagnosed metastatic disease
- Must be deemed incurable by all of the following:
- Salvage surgery
- Radiotherapy
- Measurable disease ≥ 1 cm by conventional techniques, flexible fiberoptic laryngoscopy, or examination under anesthesia
- No more than 2 prior conventional or investigational systemic therapies for categorically incurable local-regional or distant disease
- No known primary brain tumor or brain metastases
- ECOG performance status 0-1
- Life expectancy ≥ 6 months
- WBC > 3,000/mm³
- Absolute neutrophil count > 1,500/mm³
- Platelet count > 100,000/mm³
- Hemoglobin > 8 g/dL
- Bilirubin normal
- AST and ALT ≤ 2.5 times upper limit of normal
- Creatinine normal OR creatinine clearance > 60 mL/min
- Proteinuria ≤ +1 on 2 consecutive urine dipsticks taken ≥ 1 week apart
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- History of nonmelanoma skin cancer or other prior malignancy allowed provided the cancer has been in remission for > 3 years
- No history of allergic reaction attributed to compounds of similar chemical or biological composition to AZD2171
Where it is running
- Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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