Multimodality Risk Adapted Tx Including Induction Chemo for SCCHN Amenable to Transoral Surgery
Condition: Head and Neck Cancer; Squamous Cell Carcinoma of the Head and Neck
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck
Intervention: Carboplatin; Paclitaxel; Lapatinib; Cisplatin; Cisplatin; Ipsilateral Radiation; Bilateral Radiation; Transoral Surgery
Intervention description: Weekly carboplatin given intravenously for 6 weeks during induction chemotherapy.; Weekly paclitaxel given intravenously prior to carboplatin infusion for 6 weeks during induction chemotherapy.; Lapatinib (1000mg) taken by mouth once a day either one hour before or one hour after a meal for 6 weeks during induction chemotherapy. Participants deemed high risk following transoral surgery will additionally take lapatinib daily concurrently with their chemoradiation therapy.; Weekly cisplatin given intravenously for 6 weeks concurrent with ipsilateral radiation. Alternative regimens may be substituted for cisplatin in patients who are not candidates for cisplatin at the discretion of the investigator. If carboplatin is used, a maximum of 125 mL/min must be used, as per standard of care.; Cisplatin given once every 3 week cycle intravenously for 5-7 weeks concurrent with bilateral radiation and daily lapatinib. Alternative regimens may be substituted for cisplatin in patients who are not candidates for cisplatin at the discretion of the investigator. If carboplatin is used, a maximum of 125 mL/min must be used, as per standard of care.; After transoral surgery, subjects deemed medium risk will receive ipsilateral radiation as per standard of care 5 days/week for 6 weeks concurrent with weekly cisplatin.; After transoral surgery, subjects deemed high risk will receive bilateral radiation as per standard of care 5 days/week for 5-7 weeks concurrent with cisplatin every 3 weeks and daily lapatinib.; Transoral resection by robotic or microscopic approach, which will be at the discretion of the treating surgeon.
Intervention MeSH terms: Paclitaxel; Cisplatin; Carboplatin; Lapatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Head and neck cancer; Squamous Cell Carcinoma; Phase II; Transoral Surgery; Induction Chemotherapy; Carboplatin; Paclitaxel; Lapatinib

Summary:

      The purpose of this study is to see if a three method risk adapted design using induction
      chemotherapy, transoral surgery and radiation chemotherapy will lessen toxic effects and make
      treatment of squamous cell carcinoma of the head and neck (SCCHN) better.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previously untreated, histologically proven primary squamous cell carcinoma arising in
             the oral cavity, oropharynx, or supraglottic larynx, and amenable to transoral
             approach

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (see Appendix C)

          -  Measurable disease as per Response Evaluation Criteria In Solid Tumors (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
             Cockcroft-Gault

          -  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 human chorionic gonadotropin (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:

          -  tumor 1-node 0 (T1N0) disease or tumor 2-node 0 (T2N0) disease

          -  Any metastatic disease

          -  Not considered eligible for any of the chemotherapy agents included in the induction
             regimen.

          -  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
             contraception