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)
This trial is active, not recruiting.
|Condition||head & neck cancer|
|Treatment||cetuximab, imrt, albumin-bound paclitaxel (abraxane®)|
|Sponsor||Memorial Sloan Kettering Cancer Center|
|Start date||August 2008|
|End date||August 2016|
|Trial size||30 participants|
|Trial identifier||NCT00736619, 08-084|
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 of cetuximab + radiation. Albumin-bound paclitaxel and cetuximab both are chemotherapy drugs which are administered by vein.
Previous studies have shown that albumin-bound paclitaxel can kill head and neck cancer cells when given alone or in combination with chemotherapy. The purpose of this study is to establish a safe dose range of albumin-bound paclitaxel given in combination with cetuximab and radiation therapy. The investigators want to find out what effects, good and/or bad, the albumin-bound paclitaxel has on you and your head and neck cancer.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Basking Ridge, NJ||Memorial Sloan Kettering Cancer Center||no longer recruiting|
|Commack, NY||Memorial Sloan Kettering Cancer Center||no longer recruiting|
|New York, NY||Memorial Sloan Kettering Cancer Center||no longer recruiting|
|Rockville Centre, NY||Memorial Sloan Kettering at Mercy Medical Center||no longer recruiting|
|Sleepy Hollow, NY||Memoral Sloan Kettering Cancer Center@Phelps||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
To establish the phase II recommended dose of weekly intravenous albumin-bound paclitaxel (Abraxane®) given concurrently with weekly cetuximab + definitive radiation therapy (IMRT) for patients with HNSCC.
time frame: conclusion of study
To establish the safety and tolerability of weekly albumin-bound paclitaxel + cetuximab + RT for patients with HNSCC.
time frame: conclusion of study
Male or female participants from 18 years up to 100 years old.
Inclusion Criteria: - 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 Criteria: - 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
|Official title||Phase I Study of 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)|
|Principal investigator||David Pfister, MD|
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