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Head and Neck CancerPhase 2NCT01412229

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

A Phase 2 study testing Cetuximab, Nab-paclitaxel and Carboplatin in people with Head and Neck Cancer, run by UNC Lineberger Comprehensive Cancer Center at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
Cetuximab, Nab-paclitaxel and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
3 sitesUnited States
Study dates
Feb 2012to Dec 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 30Show fewer
  • 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.

Who cannot join

  • 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).

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Vanderbilt University

    Nashville, Tennessee, 37232

  • University of Washington

    Seattle, Washington, 98194

Other trials in United States

About this study

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

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.

Read the 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.

Keywords
Head and neck cancer, Phase II, Locally advanced, Squamous Cell, Carboplatin, Nab-paclitaxel, Abraxane, Cetuximab, Induction, Chemotherapy
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CetuximabDrug

    Also called Erbitux

    Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy.

  • Nab-paclitaxelDrug

    Also called Abraxane

    Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks.

  • CarboplatinDrug

    Also called Paraplatin

    Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks.

Study groups in NCT01412229
Study groupRoleWhat they receive
TreatmentExperimental* nab-paclitaxel 100mg/m2 * Carboplatin area under curve (AUC)2 (IV) * Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks
Receives: Drug: Cetuximab; Drug: Nab-paclitaxel; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Response Rate Following Induction Chemotherapy

    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.

    Measured: 9 weeks

Secondary outcomes (8)

  1. Rate of Complete Response Following 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.

    Measured: Baseline evaluation to 3 weeks after induction chemotherapy

  2. Progression Free Survival

    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)

    Measured: 1 year

  3. Objective Response Rate (CR+PR)

    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.

    Measured: 20 weeks

  4. Complete Response Rate (CR)

    Complete Response Rate as defined by RECIST 1.1 after induction chemotherapy followed by definitive chemoradiation

    Measured: 20 weeks

  5. Overall Survival

    Rate of Overall Survival

    Measured: 1 year

  6. Number of Participants With at Least One Grade 3-4 Toxicity

    Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.

    Measured: 9 Weeks

  7. Number of Participants With at Least One Grade 3-4 Toxicity, Listed by Event

    Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.

    Measured: 24 Weeks

  8. Patient-reported Quality of Life Scores

    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.

    Measured: screening until one year after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2011 (estimated)
  2. Study startFeb 2012
  3. Primary completion20 Jun 2015
  4. Study completionDec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01412229
Sponsor's protocol ID
LCCC1103
Status last verified
Sep 2020
First submitted
5 Aug 2011
Last updated
23 Nov 2020
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cetuximab, Nab-paclitaxel and Carboplatin in people with Head and Neck Cancer, run by UNC Lineberger Comprehensive Cancer Center at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 30 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Response Rate Following Induction Chemotherapy (time frame: 9 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01412229.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2020.

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