Ph 2 Intensification Regimen for Previously Untreated, Resectable, Advanced Squamous Cell Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Intervention: Cisplatin; Paclitaxel; Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation; Triple endoscopy and biopsy
Intervention description: Patients will receive Cisplatin (30 mg/m2 i.v.) daily x 3 days in week 1.; Patients will receive Paclitaxel (45 mg/m2i.v.) infusion over 3 hours during weeks 7,8,9,10; Patients will receive Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation to tumor and involved regional nodes 20Gy over 10 daily (M-F) treatments (2 Gy Fractions with 6 millivolts photons)week 1 and 2.; Resection of the primary tumor: Patients must have surgery performed according to the following surgical guidelines. The extent of the surgical resection will be dictated by the extent of the tumor at the time of initial evaluation. The primary lesion must be widely excised using accepted criteria for adequate excision depending on the region involved. All patients will undergo percutaneous endoscopic gastrostomy tube placement at the time of endoscopy and biopsies.
Intervention MeSH terms: Paclitaxel; Cisplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage III squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the lip and oral cavity; stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx; stage II squamous cell carcinoma of the hypopharynx

Summary:

      RATIONALE: Drugs used in chemotherapy, such as cisplatin and paclitaxel, 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. Giving combination
      chemotherapy together with radiation therapy before surgery may make the tumor smaller and
      reduce the amount of normal tissue that needs to be removed. Giving these treatments after
      surgery may kill any tumor cells that remain after surgery.

      PURPOSE: This phase II trial is studying how well giving cisplatin and paclitaxel together
      with radiation therapy and surgery works in treating patients with advanced cancer of the
      oral cavity, oropharynx, or hypopharynx that can be removed by surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have a Karnofsky Performance Index ≥60%

          -  Patients must be over the age of 18.

          -  Patients must have a life expectancy of at least 6 months.

          -  Women of childbearing age must have a negative serum pregnancy test and agree to use
             an effective method of contraceptive.

          -  Patients with a cardiac history should be cleared with a medical internist. In
             general, patients with a history of prior bradyarrythmias, atrioventricular (AV)
             conduction defects or marginal cardiac function will be eligible.

          -  Patients must have resectable stage III, stage IVA, stage IVB (without distant
             metastases) squamous cell carcinoma of the oral cavity, oropharynx, or hypopharynx.
             Hypopharyngeal carcinomas may also be stage II.

          -  Patients must not have had prior chemotherapy or radiotherapy (to the primary site or
             nodes).

          -  Patients may not be planning to receive while on study concomitant immunotherapy or
             hormonal therapy, except oral contraceptives or hormone replacement therapy.

          -  Patients must have adequate hepatic function documented by a normal serum bilirubin 0-
             1.5mg/L and serum transaminases < 4 x upper limit.

          -  Patients must have adequate renal function documented by a serum creatinine not above
             upper institutional normal limits and/or 24 hour OR calculated creatinine clearance
             >60 ml/min. using the following formula:

             (140-age) x Wt (kg) x .85 (if Estimated Creatinine Clearance = 72 x Creatinine (mg/dl)
             female)

          -  Patients must have adequate bone marrow function documented by platelet count ≥
             100,000 and absolute neutrophil count ≥ 2,000.

          -  Patients will have surgery according to Section 5.3. Operative and pathology reports
             must be sufficiently detailed to confirm that surgery was done according to the
             guidelines.

          -  Patients must be examined by a multi-modality team (consisting of a head and neck
             surgeon, medical oncologist, and radiation oncologist) prior to entry on study.

          -  All patients must be informed of the investigational nature of this study and must
             sign and give written informed consent in accordance with institutional and federal
             guidelines.

        Exclusion Criteria:

          -  Distant metastases.

          -  Prior malignancy, except for adequately treated basal cell (or squamous cell) skin
             cancer, in situ cervical cancer, or other cancer for which the patient has been
             disease-free for five years.

          -  Any condition that would be considered a contraindication for fluid challenge.

          -  Pregnant or lactating women may not participate.

          -  History of demyelinating neurological disorder, such as multiple sclerosis

          -  History of pancytopenia or aplastic anemia.