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Multimodality Risk Adapted Therapy Including Carboplatin/Paclitaxel/Lapatinib as Induction for Squamous Cell Carcinoma of the Head and Neck Amenable to Transoral Surgical Approaches

Phase 2
18 Years
Open (Enrolling)
Head and Neck Cancer, Squamous Cell Carcinoma of the Head and Neck

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Trial Information

Multimodality Risk Adapted Therapy Including Carboplatin/Paclitaxel/Lapatinib as Induction for Squamous Cell Carcinoma of the Head and Neck Amenable to Transoral Surgical Approaches

This is a single-arm non-randomized two-stage phase II trial in previously untreated
patients with squamous cell carcinoma of the head and neck (SCCHN) arising in the oral
cavity, oropharynx, or supraglottic larynx amenable to a transoral surgical approach.
Treatment will consist of 3 parts: neoadjuvant induction with weekly carboplatin and
paclitaxel in combination with daily lapatinib for 6 weeks (PART 1) prior to transoral
surgery (PART 2). Post-operative treatment (PART 3) will vary depending on the risk
category assigned to the patient following surgery as follows: no further treatment or
treatment limited to involved field radiation (low risk), ipsilateral radiation concurrent
with weekly chemotherapy ( medium risk); or cisplatin every 3 weeks and daily lapatinib
concurrent with bilateral radiation (high risk).

Inclusion Criteria:

- Previously untreated, histologically proven primary squamous cell carcinoma arising
in the oral cavity, oropharynx, or supraglottic larynx, and amenable to transoral

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (see Appendix C)

- Measurable disease as per RECIST1.1

- Age ≥18 years

- Adequate bone marrow function as demonstrated by: Absolute neutrophil count (ANC) ≥
1,500 cells/mm3; Hgb > 10 g/dL (use of transfusion to reach this threshold prior to
study initiation is acceptable); Platelet count ≥ 100,000/mm3

- Adequate hepatic and renal function as demonstrated by: Aspartate aminotransferase
(AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN); Total
serum bilirubin ≤1.5 mg/dL; Creatinine clearance (CrCL) ≥ 40mL/min as measured via

- Left ventricular ejection fraction (LVEF) must be > the lower limit of normal (LLN)
per institutional standards by either echocardiography or radionuclide-based multiple
gated acquisition (MUGA)

- Negative serum β-hCG pregnancy test within 72 hours of day 1 of induction
chemotherapy in women of child-bearing potential

- All males and females of childbearing potential must agree to use adequate
contraception during the study. Adequate contraception is defined as any medically
recommended method (or combination of methods) as per standard of care. Females of
non-childbearing potential are those who are postmenopausal greater than 1 year or
who have had a bilateral tubal ligation or hysterectomy

- Signed an institutional review board (IRB)-approved informed consent document for
this protocol.

Exclusion Criteria:

- T1N0 disease or T2N0 disease

- Any metastatic disease

- Not considered eligible for any of the chemotherapy agents included in the induction

- Current active hepatic or biliary disease (with exception of patients with Gilbert's
syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease
per investigator assessment)

- Major surgery within 3 weeks prior to day 1 of study treatment from which the patient
has not completely recovered

- Current use of a prohibited medication or requires any of these medications during
treatment with lapatinib prior to study entry

- Receiving any investigational agent currently, or within 2 weeks of Day 1 of
treatment on this study

- Active, serious infection, medical, or psychiatric condition that would represent an
inappropriate risk to the patient or would likely compromise achievement of the
primary study objective, including unstable angina, serious uncontrolled cardiac
arrhythmia, uncontrolled infection, or myocardial infarction ≤ 6 months prior to
study entry

- Adequate swallowing function or gastric-tube for drug administration. Of note,
lapatinib can be administered via G-tube in a slurry for patients who cannot swallow

- Other prior or concomitant malignancies with the exception of: Non-melanoma skin
cancer; In-situ malignancy; Low-risk prostate cancer after curative therapy; Other
cancer for which the patient has been disease free for ≥ 3 years

- Pregnant or lactating women, or adults of reproductive potential who do not agree to
use adequate contraception during study treatment (see definition of adequate

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Response Rate

Outcome Description:

Evaluation of target lesions through tumor imaging (CT scan, MRI, and/or chest x-ray) at 3-5 weeks post induction chemotherapy. Overall response rate will be based on RECIST criteria.

Outcome Time Frame:

11 weeks

Safety Issue:


Principal Investigator

Jared Weiss, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of North Carolina, Chapel Hill


United States: Institutional Review Board

Study ID:

LCCC 1125



Start Date:

June 2012

Completion Date:

December 2018

Related Keywords:

  • Head and Neck Cancer
  • Squamous Cell Carcinoma of the Head and Neck
  • Head and neck cancer
  • Squamous Cell Carcinoma
  • Phase II
  • Transoral Surgery
  • Induction Chemotherapy
  • Carboplatin
  • Paclitaxel
  • Lapatinib
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms



The University Of North Carolina At Chapel Hill Chapel Hill, North Carolina  27599-7235