Phase 2 Sequential and Concurrent Chemoradiation for Advanced Nasopharyngeal Carcinoma (NPC)
Condition: Stage II Lymphoepithelioma of the Nasopharynx; Stage II Squamous Cell Carcinoma of the Nasopharynx; Stage III Lymphoepithelioma of the Nasopharynx; Stage III Squamous Cell Carcinoma of the Nasopharynx; Stage IV Lymphoepithelioma of the Nasopharynx; Stage IV Squamous Cell Carcinoma of the Nasopharynx
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Nasopharyngeal Carcinoma
Intervention: docetaxel; cisplatin; carboplatin; fluorouracil; 3-dimensional conformal radiation therapy; intensity-modulated radiation therapy
Intervention description: Given IV; Given IV; Given IV; Given IV; Undergo 3-dimensional conformal or intensity-modulated radiotherapy; Undergo 3-dimensional conformal or intensity-modulated radiotherapy
Intervention MeSH terms: Carboplatin; Docetaxel; Fluorouracil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No

Summary:

      This phase 2 trial is studying whether giving a combination of docetaxel, cisplatin, and
      fluorouracil chemotherapy followed by the combination of cisplatin with radiation therapy
      works in treating patients with advanced nasopharyngeal cancer. Drugs used in chemotherapy,
      such as docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of
      tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy
      uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a
      high dose of radiation directly to the tumor may kill more tumor cells and cause less damage
      to normal tissue. Giving combination chemotherapy together with radiation therapy may kill
      more tumor cells.
    

Eligibility criteria:

        INCLUSION CRITERIA

          -  Histologically- or cytologically-confirmed nasopharyngeal carcinoma meeting the
             following criteria:

               -  WHO type I, II, or III

               -  Stage II to IVB disease (minimally T2a, N0, M0 or any T any, N1, M0)

               -  Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1
                  dimension as ≥ 20 mm by conventional techniques or as ≥ 10 mm by spiral CT scan

               -  Prior diagnostic surgery(s) at the primary site or neck allowed provided there is
                  still measurable disease present

               -  Without known brain metastases

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1

          -  Life expectancy > 3 months

          -  Absolute neutrophil count (ANC) ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ≤ 2.5 times ULN

          -  Creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 55 mL/min (NOTE: * Patients with
             creatinine > grade 1 but < grade 3, hearing loss ≥ grade 2, and peripheral neuropathy
             ≥ grade 2 are eligible provided they receive carboplatin in place of cisplatin
             throughout study treatment)

          -  Hearing loss < grade 2. Hearing loss grade 2 or greater attributable to tumor
             obstruction, when the bone conduction in the audiogram is consistent with less than
             grade 2, is permissible for cisplatin. Hearing loss will be evaluated by hearing in
             the best ear. If hearing loss is grade 2, patients are still eligible but should
             receive carboplatin throughout the protocol instead of cisplatin.

          -  Peripheral motor/sensory neuropathy < grade 2. If peripheral neuropathy is grade 2,
             patients are still eligible but should receive carboplatin throughout the protocol
             instead of cisplatin.

          -  Fertile patients must use effective contraception prior to and during study treatment

        EXCLUSION CRITERIA

          -  Uncontrolled intercurrent illness including, but not limited to, any of the following:

               -  Ongoing or active infection

               -  Symptomatic congestive heart failure

               -  Unstable angina pectoris

               -  Cardiac arrhythmia

               -  Psychiatric illness or social situations that preclude compliance with study
                  requirements

               -  Clinically-significant cardiovascular disease

               -  Cerebrovascular accident within the past 6 months

               -  Myocardial infarction or unstable angina within the past 6 months

               -  New York Heart Association (NYHA) class II to IV congestive heart failure

               -  Serious and inadequately controlled cardiac arrhythmia

               -  Significant vascular disease (eg, aortic aneurysm, history of aortic dissection)

               -  Clinically-significant peripheral vascular disease

          -  History of allergic reaction attributed to compounds of similar chemical or biologic
             composition to docetaxel, cisplatin, carboplatin, fluorouracil, bevacizumab, or other
             agents used in this study

          -  Known brain metastases

          -  Concurrent combination antiretroviral therapy for HIV-positive patients

          -  Prior chemotherapy or radiotherapy for nasopharyngeal carcinoma

          -  Pregnant or nursing