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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)


Phase 1
18 Years
N/A
Open (Enrolling)
Both
HEAD & NECK Cancer

Thank you

Trial Information

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)


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

conclusion of study

Safety Issue:

Yes

Principal Investigator

Matthew Fury, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

08-084

NCT ID:

NCT00736619

Start Date:

August 2008

Completion Date:

August 2013

Related Keywords:

  • Head & Neck Cancer
  • MAB C225(CETUXIMAB)(ANTI-EGFR)
  • TAXOL (PACLITAXEL)
  • Radiation Therapy
  • 08-084
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Memorial Sloan-Kettering Cancer CenterBasking Ridge, New Jersey  
Memorial Sloan-Kettering at Mercy Medical CenterRockville Centre, New York  
Memoral Sloan Kettering Cancer Center@PhelpsSleepy Hollow, New York