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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center Abraxis BioScience Inc. NCCN (NATL COMP CA NETWORK) |
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Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00736619 |
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. We want to find out what effects, good and/or bad, the albumin-bound paclitaxel has on you and your head and neck cancer.
Condition | Intervention | Phase |
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Head & Neck Cancer |
Other: Cetuximab, IMRT, Albumin-bound paclitaxel (Abraxane®) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
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) |
Estimated Enrollment: | 30 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | August 2011 |
Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Cetuximab loading dose, 400 mg/m2 intravenously (IV) IMRT, 1 fraction/day, up to total of approximately 70 Gy, over approximately 33 treatment days
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Other: Cetuximab, IMRT, Albumin-bound paclitaxel (Abraxane®)
All patients will receive standard treatment with definitive radiation therapy (IMRT, intensity-modulated radiation therapy) administered concurrently with cetuximab (400 mg/m2 intravenous loading dose one week prior to radiation therapy, followed by 250 mg/m2 weekly intravenous infusions). To explore different dose levels of nanoparticle albumin-bound paclitaxel (Abraxane®) given intravenously weekly with the standard regimen of weekly cetuximab + daily radiation therapy. The total number of planned cetuximab infusions is 8 (loading dose, plus 7 weekly infusions concurrent with radiation therapy). The total number of planned albuminbound paclitaxel infusions is 7 (all concurrent with radiotherapy). Five dose levels of weekly intravenous (IV) albumin-bound paclitaxel will be explored. |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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.
Exclusion Criteria:
Contact: Matthew Fury, MD, PhD | furym@mskcc.org | |
Contact: David Pfister, MD | pfisterd@mskcc.org |
United States, New Jersey | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
Basking Ridge, New Jersey, United States | |
Contact: Matthew Fury, MD, PhD furym@mskcc.org | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
Contact: Matthew Fury, MD, PhD furym@mskcc.org | |
Contact: David Pfister, MD pfisterd@mskcc.org | |
Principal Investigator: Matthew Fury, MD, PhD | |
Memoral Sloan Kettering Cancer Center@Phelps | Recruiting |
Sleepy Hollow, New York, United States | |
Contact: Matthew Fury, MD, PhD furym@mskcc.org | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
Commack, New York, United States | |
Contact: Matthew Fury, MD, PhD furym@mskcc.org | |
Memorial Sloan-Kettering at Mercy Medical Center | Recruiting |
Rockville Centre, New York, United States | |
Contact: Matthew Fury, MD, PhD furym@mskcc.org |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Matthew Fury, MD, PhD ) |
Study ID Numbers: | 08-084 |
Study First Received: | August 15, 2008 |
Last Updated: | July 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00736619 History of Changes |
Health Authority: | United States: Institutional Review Board |
MAB C225(CETUXIMAB)(ANTI-EGFR) TAXOL (PACLITAXEL) Radiation Therapy |
Cetuximab Carcinoma, Squamous Cell of Head and Neck Antimitotic Agents Squamous Cell Carcinoma Carcinoma Paclitaxel Head and Neck Neoplasms |
Epidermoid Carcinoma Tubulin Modulators Neoplasms, Squamous Cell Carcinoma, Squamous Cell Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Cetuximab Mitosis Modulators Antimitotic Agents Pharmacologic Actions Carcinoma Neoplasms |
Neoplasms by Site Paclitaxel Therapeutic Uses Head and Neck Neoplasms Tubulin Modulators Neoplasms, Squamous Cell Carcinoma, Squamous Cell Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |