Status:
TERMINATED
Study of Albumin Bound-Paclitaxel for Treatment of Recurrent or Metastatic Head and Neck Cancer With Cetuximab
Lead Sponsor:
University of California, Irvine
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Primary Objective: To assess the overall response rate (complete and partial response) to Abraxane in patients with recurrent or metastatic head and neck cancer with the addition of Cetuximab on disea...
Detailed Description
OBJECTIVES Primary Objective: To assess the overall response rate (complete and partial response) to Abraxane in patients with recurrent or metastatic head and neck cancer with the addition of Cetuxi...
Eligibility Criteria
Inclusion
- All patients must have histologically or cytologically confirmed carcinoma of the head and neck region. Primary tumor sites include: lip and oral cavity, major salivary glands, pharynx (oropharynx, nasopharynx, hypopharynx), or larynx (supraglottis, glottis, subglottis), nasal cavity and paranasal sinuses, and thyroid
- Patients must have metastatic or locally recurrent squamous cell carcinoma of the head and neck. Patients with locoregional disease must be considered incurable by means of locoregional therapy.
- All sites of disease must be assessed and designated as measurable or non-measurable disease as documented by CT, MRI, X-ray physical exam or nuclear exam. All measurable and non-measurable disease must be assessed within 28 days prior to registration.
- Patients may have prior chemotherapy for recurrent/metastatic disease. However, all chemotherapy must be completed at least 21 days prior to scheduled start of Abraxane.
- Patients must have adequate bone marrow reserve as documented by absolute neutrophil count (ANC) \> 1,500 μl and platelets \> 100,000/ μl obtained within 14 days prior to registration.
- Patients must have adequate hepatic as documented by serum bilirubin \< 1.5 x the institutional upper limit of normal. These tests must be obtained within 14 days prior to registration.
- All patients must be 18 years of age or older
- Patients must have a Zubrod performance of 0-3
Exclusion
- Patients must not have prior therapy with Abraxane
- Patients with any evidence of active or uncontrolled infection, recent myocardial infection, unstable angina, or life-threatening arrhythmia are not eligible.
- Patients with baseline grade 3 peripheral neuropathy are not eligible.
- Patients with known brain metastasis are not eligible. However, brain-imaging studies are not required for eligibility if the patient has no neurological signs or symptoms. If brain-imaging studies are performed, they must be negative for disease.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00319839
Start Date
March 1 2006
End Date
June 1 2010
Last Update
January 12 2018
Active Locations (1)
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1
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868