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) - Full Text View

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center Abraxis BioScience Inc. NCCN (NATL COMP CA NETWORK)
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00736619

Purpose

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
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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer Radiation Therapy

Drug Information available for: Paclitaxel Cetuximab

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

To establish the phase II recommended dose of weekly intravenous albuminbound paclitaxel (Abraxane®) given concurrently with weekly cetuximab + definitive radiation therapy (IMRT) for patients with HNSCC. [ Time Frame: conclusion of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To establish the safety and tolerability of weekly albumin-bound paclitaxel + cetuximab + RT for patients with HNSCC. [ Time Frame: conclusion of study ] [ Designated as safety issue: Yes ]

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
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 Cetuximab 250 mg/m2 weekly IV X 7 weeks Albumin-bound paclitaxel (Abraxane®) weekly IV X 7 weeks, according to dose escalation scheme	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.

Arms

Assigned Interventions

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

Cetuximab 250 mg/m2 weekly IV X 7 weeks
Albumin-bound paclitaxel (Abraxane®) weekly IV X 7 weeks, according to dose escalation scheme

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 chemotherapy or 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00736619

Contacts

Contact: Matthew Fury, MD, PhD		furym@mskcc.org
Contact: David Pfister, MD		pfisterd@mskcc.org

Locations

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

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Abraxis BioScience Inc.

NCCN (NATL COMP CA NETWORK)

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

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

Keywords provided by Memorial Sloan-Kettering Cancer Center:

MAB C225(CETUXIMAB)(ANTI-EGFR)
TAXOL (PACLITAXEL)
Radiation Therapy

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on September 11, 2009