Trial Search Results

Phase 2 Sequential and Concurrent Chemoradiation for Advanced Nasopharyngeal Carcinoma (NPC)

This phase II 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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Stanford University

Intervention(s):

  • Drug: docetaxel
  • Drug: cisplatin
  • Drug: carboplatin
  • Drug: fluorouracil
  • Radiation: 3-dimensional conformal radiation therapy
  • Radiation: intensity-modulated radiation therapy

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - Histologically or cytologically confirmed nasopharyngeal carcinoma meeting the
   following criteria:

      - WHO type I, II, or III

      - Stage II -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

      - No known brain metastases

   - ECOG performance status 0-1

   - Life expectancy > 3 months

   - ANC >= 1,500/mm^3

   - Platelet count >= 100,000/mm^3

   - Total bilirubin <= 1.5 times ULN

   - AST and 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

   - Not pregnant or nursing

   - Fertile patients must use effective contraception prior to and during 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.

   - No 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

      - No clinically significant cardiovascular disease

      - No cerebrovascular accident within the past 6 months

      - No myocardial infarction or unstable angina within the past 6 months

      - No NYHA class II-IV congestive heart failure

      - No serious and inadequately controlled cardiac arrhythmia

      - No significant vascular disease (e.g., aortic aneurysm, history of aortic
      dissection)

      - No clinically significant peripheral vascular disease

      - No 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

   - No concurrent combination antiretroviral therapy for HIV-positive patients

   - No prior chemotherapy or radiotherapy for nasopharyngeal carcinoma

Ages Eligible for Study

18 Years - 120 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Risa Jiron
650-736-1598
Recruiting