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Induction Chemotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by UNC Lineberger Comprehensive Cancer Center
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01412229
First received: August 5, 2011
Last updated: February 28, 2014
Last verified: February 2014
  Purpose

This is a non-randomized, open-label phase II trial of 40 patients with poor prognosis head and neck cancer, defined as surgically unresectable and/or ≥N2b disease and judged appropriate for non-surgical definitive therapy.


Condition Intervention Phase
Head and Neck Cancer
Drug: Cetuximab
Drug: Nab-paclitaxel
Drug: Carboplatin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Carboplatin, Nab-paclitaxel and Cetuximab for Induction Chemotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Resource links provided by NLM:


Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • Clinical Response Rate Following Induction Chemotherapy [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    Evaluation of target lesions via imaging with CT or MRI scans at 2-3 weeks post induction chemotherapy.


Secondary Outcome Measures:
  • Rate of Complete Response following Induction Chemotherapy [ Time Frame: Baseline evaluation to 3 weeks after induction chemotherapy ] [ Designated as safety issue: No ]
    Report the rate of complete responses, defined as disappearance of all target lesions, following induction chemotherapy.

  • Progression Free Survival and Overall Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Imaging of target lesions via CT or MRI scan post induction chemotherapy and chemoradiotherapy every 3 months for at least one year, and every 6 months for at least one year following completion of definitive chemoradiotherapy with or without surgery

  • Toxicity evaluation [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.

  • Quality of Life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    ECOG Performance status and FACT-HN will be completed at screening, 3 weeks post induction chemotherapy, 6 weeks post concomitant chemoradiotherapy, every 3 months in the first year, and every 6 months in the second year.


Estimated Enrollment: 40
Study Start Date: February 2012
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Drug: Cetuximab
Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy.
Other Name: Erbitux
Drug: Nab-paclitaxel
Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks.
Other Name: Abraxane
Drug: Carboplatin
Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks.
Other Name: Paraplatin

Detailed Description:

This is a non-randomized, open-label phase II trial of 40 patients with poor prognosis head and neck cancer, defined as surgically unresectable and/or ≥N2b disease and judged appropriate for non-surgical definitive therapy. Patients must have ECOG performance status of 0-1 with good organ function and will be treated with six weekly cycles of carboplatin, nab-paclitaxel and cetuximab prior to scheduled concomitant chemoradiation. The study is designed to evaluate whether this induction regimen can result in an improved response rate (complete response (CR) + partial response (PR)) with less toxicity than the current standard induction TPF regimen which includes docetaxel, cisplatin and 5-fluorouracil (5FU).

  Eligibility

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

Inclusion Criteria:

  • Histologically or cytologically confirmed SCCHN or poorly differentiated or undifferentiated cancer of the head and neck.
  • Measurable disease.
  • All primary sites are eligible excluding nasopharyngeal.
  • Surgically unresectable and/or N2b or greater nodal disease; NOTE: surgical unresectability will be defined as the combination of the treating surgeon's judgment of unresectability plus one of the following objective criteria:

    • Encasement of tumor or nodes to the carotid artery or ¾ encasement of the carotid artery.
    • Involvement of prevertebral musculature
    • Invasion of the bone of the skull base
    • Need for glossectomy or extensive glossal resection where functional outcome is considered unacceptable to surgeon or patient
    • Involvement of the cervical spine
    • Severe, unacceptable functional deficit that would result from any proposed definitive surgical resection.
  • ECOG performance status 0-1
  • Prior therapy:

    • Chemotherapy: No prior chemotherapy for the treatment of SCCHN.
    • Platinum chemotherapy: No previous history of carboplatin or cisplatin therapy.
    • Nab-paclitaxel: No previous treatment with nab-paclitaxel or another taxane.
    • Cetuximab: No previous treatment with cetuximab Or another EGFR inhibitor.
    • Radiation therapy: No prior radiation to the head and neck region.
  • Age > or = 18 years. Men and women are eligible for participation.
  • Must have acceptable organ and marrow function as defined below. Laboratory tests should be completed within 14 days prior to registration:

    • ANC > or = 1,500/mm3
    • Platelets > or = 100,000/mm3
    • HgB > 9g/dL
    • Total bilirubin < or = 1.5mg/dL
    • Albumin > 2.5 g/dL
    • AST(SGOT)/ALT(SGPT) < or = 2.5X institutional upper limit of normal, alkaline phosphatase < 2.5 x upper limit of normal, GFR > 30 mL/min (by standard Cockcroft and Gault formula or measured via 24 hour urine collection)
  • No pre-existing neuropathy greater than grade I
  • Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to day 1 of study treatment.
  • Women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation and for three months after completing treatment. Adequate contraception is defined as any medically recommended method (or combination of methods) as per standard of care.
  • Patients must have the ability to understand and the willingness to sign a written informed consent document.
  • Patients must have a negative result for preformed IgE antibodies to galactose-alpha-1,3,-galactose.

Exclusion Criteria:

  • Prior treatment with any of the study medications.
  • Prior radiation to any of the field required to treat the tumor.
  • Any metastatic disease.
  • The patient may have had a prior malignancy but must be disease-free for three years prior to study entry. A history of superficial non-melanoma skin cancer or in situ carcinoma of the cervix less than three years will be allowed.
  • Pregnant or lactating female
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring IV antibiotics, or psychiatric illness/social situations that would limit compliance with study requirements. Cardiac disease such as symptomatic congestive heart failure, unstable angina pectoris, or myocardial infarction will result in exclusion only if active within the past six months. Cardiac dysrhythmia will only result in exclusion if active and symptomatic (for example, rate-controlled atrial fibrillation will not result in exclusion).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01412229

Contacts
Contact: Dale Flowers, RN 919-966-4432 dale_flowers@med.unc.edu
Contact: Donna Rowe, RN 919-966-7359 donna_rowe@med.unc.edu

Locations
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Dale Flowers, RN    919-966-4432    dale_flowers@med.unc.edu   
Principal Investigator: Jared Weiss, MD         
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Principal Investigator: Jill Gilbert, MD         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98194
Principal Investigator: Renato Martins, MD, MPH         
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Celgene Corporation
Investigators
Principal Investigator: Jared Weiss, MD University of North Carolina, Chapel Hill
  More Information

Additional Information:
No publications provided

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01412229     History of Changes
Other Study ID Numbers: LCCC 1103
Study First Received: August 5, 2011
Last Updated: February 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
Head and neck cancer
Phase II
Locally advanced
Squamous Cell
Carboplatin
Nab-paclitaxel
Abraxane
Cetuximab
Induction
Chemotherapy

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Carboplatin
Cetuximab
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 20, 2014