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

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ClinicalTrials.gov Identifier: NCT01412229
Recruitment Status : Completed
First Posted : August 9, 2011
Results First Posted : July 2, 2017
Last Update Posted : November 23, 2020
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE August 5, 2011
First Posted Date  ICMJE August 9, 2011
Results First Submitted Date  ICMJE March 29, 2017
Results First Posted Date  ICMJE July 2, 2017
Last Update Posted Date November 23, 2020
Study Start Date  ICMJE February 2012
Actual Primary Completion Date June 20, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2017)
Clinical Response Rate Following Induction Chemotherapy [ Time Frame: 9 weeks ]
Evaluation of target lesions via imaging with CT or MRI scans at 2-3 weeks post induction chemotherapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.
Original Primary Outcome Measures  ICMJE
 (submitted: August 8, 2011)
Clinical Response Rate Following Induction Chemotherapy [ Time Frame: 9 weeks ]
Evaluation of target lesions via imaging with CT or MRI scans at 2-3 weeks post induction chemotherapy.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2018)
  • Rate of Complete Response Following Induction Chemotherapy [ Time Frame: Baseline evaluation to 3 weeks after induction chemotherapy ]
    Report the rate of complete responses, defined as disappearance of all target lesions, following induction chemotherapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions.
  • Progression Free Survival [ Time Frame: 1 year ]
    Rate of Progression Free Survival (Time to death or progression defined by imaging of target lesions via CT or MRI scan post induction chemotherapy and chemoradiotherapy every 3 months for one year)
  • Objective Response Rate (CR+PR) [ Time Frame: 20 weeks ]
    Objective Response Rate as defined by RECIST 1.1 after induction chemotherapy followed by definitive chemoradiation. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.
  • Complete Response Rate (CR) [ Time Frame: 20 weeks ]
    Complete Response Rate as defined by RECIST 1.1 after induction chemotherapy followed by definitive chemoradiation
  • Overall Survival [ Time Frame: 1 year ]
    Rate of Overall Survival
  • Number of Participants With at Least One Grade 3-4 Toxicity [ Time Frame: 9 Weeks ]
    Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.
  • Number of Participants With at Least One Grade 3-4 Toxicity, Listed by Event [ Time Frame: 24 Weeks ]
    Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.
  • Patient-reported Quality of Life Scores [ Time Frame: screening until one year after treatment ]
    Functional Assessment of Cancer Therapy - Head & Neck (FACT-HN) is the FACT-G and a 12 item head and neck cancer specific subscale completed at screening (Screening), 3 weeks post induction chemotherapy (Treatment Break), 7 weeks post concomitant chemoradiotherapy (7 weeks Off Treatment), one year post off-treatment (1 year Off Treatment). The FACT-G is a 27 item measure of general QOL assessing function in 4 domains: physical well-being (PWB), social-family well-being (SFWB), emotional well-being (EWB) and functional well-being (FWB). Items are rated by patients on a Likert scale from 0 to 4 (resulting in potential total scores between 0 and 156). Higher scores represent better QOL.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2011)
  • Rate of Complete Response Following Induction Chemotherapy [ Time Frame: Baseline evaluation to 3 weeks after induction chemotherapy ]
    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 ]
    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 ]
    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 ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Induction Chemotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Official Title  ICMJE A Phase II Study of Carboplatin, Nab-paclitaxel and Cetuximab for Induction Chemotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Brief Summary 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.
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 Eastern Cooperative Oncology Group (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 docetaxel, cisplatin and 5-fluorouracil (TPF) regimen.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Head and Neck Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: Treatment
  • nab-paclitaxel 100mg/m2
  • Carboplatin area under curve (AUC)2 (IV)
  • Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks
Interventions:
  • Drug: Cetuximab
  • Drug: Nab-paclitaxel
  • Drug: Carboplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 8, 2011)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2019
Actual Primary Completion Date June 20, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 epidermal growth factor receptor (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:

    • Absolute Neutrophil Count (ANC) > or = 1,500/mm3
    • Platelets > or = 100,000/mm3
    • Hemoglobin (Hgb) > 9g/dL
    • Total bilirubin < or = 1.5mg/dL
    • Albumin > 2.5 g/dL
    • Aspartate aminotransferase (AST)/Alanine Aminotransferase (ALT) < or = 2.5 times institutional upper limit of normal, alkaline phosphatase < 2.5 x upper limit of normal, glomerular filtration rate (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 immunoglobulin E (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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01412229
Other Study ID Numbers  ICMJE LCCC1103
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UNC Lineberger Comprehensive Cancer Center
Study Sponsor  ICMJE UNC Lineberger Comprehensive Cancer Center
Collaborators  ICMJE Celgene Corporation
Investigators  ICMJE
Principal Investigator: Jared Weiss, MD University of North Carolina, Chapel Hill
PRS Account UNC Lineberger Comprehensive Cancer Center
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP