Status:
COMPLETED
Weekly Nanoparticle Albumin-Bound Paclitaxel (Abraxane) + Weekly Cetuximab + Radiation Therapy (IMRT, Intensity-Modulated Radiation Therapy) in Patients With Stage III-IVB Head and Neck Squamous Cell Carcinoma (HNSCC)
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Celgene Corporation
National Comprehensive Cancer Network
Conditions:
HEAD & NECK Cancer
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
Brief Summary
For patients with this type of cancer, one standard treatment option is cetuximab (Erbitux®) + radiation. We wish to study the addition of albumin-bound paclitaxel (Abraxane®) to this standard regimen...
Eligibility Criteria
Inclusion
- Locally and/or regionally advanced head and neck squamous cell carcinoma (AJCC Stage III-IVB)
- Karnofsky performance status ≥ or = to 70%
- Adequate bone marrow function: absolute neutrophil count ≥ or = to 1,500/μl, platelets ≥ or = to 100,000/μl, hemoglobin ≥ or = to 9 gm/dl
- Adequate hepatic function:
- Total Bilirubin ≤ or = to institutional upper limit of normal (ULN) AST and ALT and Alkaline Phosphatase must be within the range allowing for eligibility. In determining eligibility the more abnormal of the two values (AST or ALT) should be used
- Patients must have adequate renal function: serum creatinine ≤ 1.5 mg/dl or estimated creatinine clearance of ≥ 45 ml/min by Cockcroft and Gault method
- Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter
- Women of childbearing potential must have a negative pregnancy test
- Patients must have ability to understand and the willingness to sign a written informed consent document
Exclusion
- Other active malignancy, other than indolent malignancies which the investigator determines are unlikely to interfere with treatment or efficacy analysis. For example, patients with non-melanoma skin cancer, in situ carcinoma of the cervix, or prostate cancer within the no current biochemical (PSA) or radiologic evidence of disease may enroll
- Prior radiation therapy for head and neck cancer
- Patients with multifocal peripheral sensory alterations or paresthesias (including tingling) interfering with function, per patient report (example: activities of daily living)
- Inability to comply with study and/or follow-up procedures
- Women who are pregnant or lactating
- Serious concomitant medical disorders (for example, active infection, uncontrolled seizure disorder, unstable angina, auto-immune connective tissue disease) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study
- History of severe infusion reaction to a monoclonal antibody
- Patients with nasopharyngeal carcinoma are not eligible
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00736619
Start Date
August 1 2008
End Date
August 1 2016
Last Update
August 10 2016
Active Locations (5)
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1
Memorial Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
2
Memorial Sloan Kettering Cancer Center
Commack, New York, United States
3
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
4
Memorial Sloan Kettering at Mercy Medical Center
Rockville Centre, New York, United States