Induction Chemotherapy With ACF Followed by Chemoradiation Therapy for Adv. Head & Neck Cancer
Condition: Head and Neck Neoplasms
MeSH terms: Head and Neck Neoplasms
Intervention: paclitaxel albumin-stabilized nanoparticle formulation; Cisplatin; Fluorouracil; Intensity modulated radiation therapy; Cetuximab; Quality-of-life assessment
Intervention description: ACF baseline, IMRT baseline, Day 7, Week 12, months 6 and 12
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Fluorouracil; Cetuximab; Antibodies; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies the safety and effectiveness of an induction chemotherapy (ACF)
      consisting of paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel),
      cisplatin and fluorouracil followed by chemoradiation therapy in treating patients with stage
      III-IV squamous cell cancer of the head and neck. ACF may be an effective way to reduce or
      downgrade locally aggressive tumors, and improve the chance of eradication by chemoradiation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient must have selected stage III or IVa/b head and neck squamous cell carcinoma
             (HNSCC); all patients must have T2-T4 primary tumors; (patients with T1 tumors will be
             excluded); although most of these patients will have regional nodal disease, patients
             with no nodal disease will also be eligible

          -  Patient must have disease at the oropharynx, hypopharynx, larynx, or oral cavity
             sub-sites

          -  Patient must have measurable disease defined as lesions that can be accurately
             measured in at least one dimension (longest diameter to be recorded) as >= 10 mm with
             CT scan

          -  Patient must be >= 18 years of age.

          -  Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status =< 2

          -  Patient must have adequate bone marrow and organ function as defined below:

               -  Absolute neutrophil count (ANC) >= 1500/mcL

               -  Platelets > 100,000/mcL

               -  Hemoglobin > 9.0 g/dL

               -  Total bilirubin =< 1.5 mg/dL

               -  Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x upper
                  limit of normal (ULN)

               -  Alkaline phosphatase =< 2.5 x ULN

               -  Serum creatinine < 1.8 mg/dL

          -  Women of childbearing potential and men must agree to use adequate contraception
             (hormonal or barrier method of birth control, abstinence) prior to study entry, for
             the duration of study participation, and for 3 months after completing treatment.
             Should a woman become pregnant or suspect she is pregnant while participating in this
             study, she must inform her treating physician immediately

          -  Patient must be able to understand and willing to sign an Institutional Review Board
             (IRB)-approved written informed consent document

          -  Patient with uncontrolled diabetes or fasting blood glucose level of greater than 200
             mg/dL will be eligible for enrollment but will not be evaluable for PET imaging

        Exclusion Criteria:

          -  Patient must not have had prior chemotherapy, prior epidermal growth factor receptor
             (EGFR) targeted therapy, or prior radiation therapy for HNSCC

          -  Patient must not have disease at the nasopharyngeal, sinus, or other sub-site not
             specified in the inclusion criteria; patient must not have unknown primary squamous
             cell carcinoma of the head and neck

          -  Patient must not have a history of prior invasive malignancy diagnosed within 3 years
             prior to study enrollment other than local stage non-melanoma skin cancer

          -  Patient must not be receiving any other investigational agents

          -  Patient must not have a history of allergic reactions attributed to compounds of
             similar chemical or biologic composition to any of the agents used in this study

          -  Patient must not be taking cimetidine or allopurinol. If currently taking either of
             these medications, patient must discontinue for one week before receiving treatment
             with nab-paclitaxel

          -  Patient must not have an uncontrolled intercurrent illness including, but not limited
             to, ongoing or active serious infection, symptomatic congestive heart failure,
             unstable angina pectoris, cardiac arrhythmia, or serious psychiatric illness/social
             situations that would limit compliance with study requirements

          -  Patient must not be pregnant and/or breastfeeding; a negative serum or urine pregnancy
             test is required at screening for all female patients of childbearing potential

          -  Patient must not be known to be human immunodeficiency virus (HIV)-positive on
             combination antiretroviral therapy because of the potential for pharmacokinetic
             interactions with the study agents; in addition, these patients are at increased risk
             of lethal infections when treated with marrow suppressive therapy; appropriate studies
             will be undertaken in patients receiving combination antiretroviral therapy when
             indicated

          -  Patient must not have peripheral neuropathy > grade 1