Clinical trial NCT02760667 (phase 2, status: active, not recruiting)
Conditions: head and neck cancer
ICD codes: C76.0, C47.0, C49.0, C77.0, D17.0, D21.0, D36.11
Drugs: cisplatinum, docetaxel, carboplatin
SMILES: [H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H], [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, N[C@@H](CCCNC(N)=N)C(O)=O
Eligibility criteria:

        Inclusion Criteria:

          -  Biopsy proven squamous cell carcinoma of the oropharynx (tonsil, base of tongue,
             vallecula, soft palate) and supraglottis.

          -  Stages III (T1N1, T2N1, T3N0, T3N1) and stage IVA (T1N2, T2N2, T3N2, very select
             earlyT4) disease not previously treated with any method (Surgery, Radiation or
             Chemotherapy)

          -  No evidence of distant metastatic disease

          -  Fit for surgery and primary tumor assessed surgically resectable (by surgical PI) via
             transoral approach

          -  Age > 18 years

          -  Karnofsky performance status > 60%, or ECOG < 2

          -  ANC > 2,000, platelets > 100,000 and calculated creatinine clearance >50 cc/min

          -  Signed study specific consent form

          -  Protocol begins within 4 weeks of biopsy and within 3 weeks of the latest medical
             imaging.

               -  No other malignancies except cutaneous basal or squamous cell cancer within the
                  last 5 years

               -  Patients must have measurable disease based on RECIST.

          -  Men and women of child bearing potential must agree to use effective contraception
             while on the study, and women must have a negative pregnancy test, and not be
             lactating.

        Exclusion Criteria:

          -  Patients with advanced T4 cancer judged unresectable by transoral approach by surgical
             PI.

          -  Patients with N3 disease (Stage IVB).

          -  Patients with distant metastatic disease (Stage IVC).

          -  Patients with radiologically positive neck nodes with radiological evidence of
             extracapsular nodal tumor invasion.

          -  Patients having anatomy not allowing transoral access and exposure for surgery(Judged
             by the surgical PI at the time of biopsy under general anesthesia)

          -  Patients with prior head and neck cancer at any time (other than basal or squamous
             cell cancer of the skin)

          -  Coexistent second malignancy or history within 5 years of prior malignancy (other than
             basal or squamous cell cancer of the skin or curatively treated Stage I carcinoma of
             the cervix) renders the patient ineligible.

          -  Patients with peripheral neuropathy >/= grade 1 will not be eligible for the study.

          -  Patients who have had prior Taxanes or Cisplatin

          -  Patients with concurrent infection are not eligible. All patients must be afebrile for
             at least 3 days prior to start of therapy unless fever is due to tumor.

          -  Patients with coexisting medical illness of a severity that might interfere with
             treatment or follow-up, or who do not have the ability to give informed consent.

          -  Patients who have received prior radiation therapy, surgery and chemotherapy for the
             tumor being treated.

          -  Patients must not be receiving any other investigational agent while on the study.