Trials / Completed
CompletedNCT00387335
Sunitinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer
Phase II Study of Sunitinib Malate in Head and Neck Squamous Cell Carcinoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase II trial is studying how well sunitinib works in treating patients with recurrent and/or metastatic head and neck cancer. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Detailed description
OBJECTIVES: I. Determine the overall response rate of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck treated with sunitinib malate. II. Determine the toxicity of this drug in these patients. III. Determine the feasibility of administering this drug to patients with ECOG performance status 2 (cohort B). OUTLINE: This is a multicenter, cohort study. Patients are assigned to one of two cohorts according to ECOG performance status (ECOG 0-1 \[cohort A\] vs ECOG 2 \[cohort B\]). Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for at least 1 year.
Conditions
- Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
- Recurrent Metastatic Squamous Neck Cancer With Occult Primary
- 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
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | sunitinib malate | Given orally |
Timeline
- Start date
- 2006-08-01
- Primary completion
- 2010-03-01
- Completion
- 2010-03-01
- First posted
- 2006-10-13
- Last updated
- 2014-07-25
- Results posted
- 2014-01-22
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00387335. Inclusion in this directory is not an endorsement.