Phase II Evaluation of Adjuvant Hyperfractionated Radiation and Docetaxel for Intermediate Risk HPV Associated Oropharynx Cancer

Location:

Rochester, Minn.

Trial status:
Open for Enrollment
Why is this study being done?

PRIMARY OBJECTIVES: I. To assess the cumulative incidence of local/regional failure at 2 years after study registration. SECONDARY OBJECTIVES: I. To characterize the rate of acute grade 3 or higher functional mucosal adverse events (up to 1 month post-radiation therapy [XRT]) associated with adjuvant docetaxel + hyperfractionated radiotherapy (key secondary endpoint). II. To assess changes in overall survival, disease-free survival, distant failure rates, and quality of life (QOL) associated with adjuvant docetaxel and hyperfractionated radiation. III. To characterize other acute adverse events (up to 1 month post-XRT) and late grade 3 or higher non-hematologic adverse events (up to 2 years post-XRT) associated with adjuvant docetaxel + hyperfractionated radiotherapy. OUTLINE: Patients receive docetaxel intravenously (IV) over 1 hour on days1, 8, and 15 and undergo hyperfractionated intensity-modulated radiation therapy (IMRT) twice daily (BID) for on days 1-5 and 8-12 (20 fractions). After completion of study treatment, patients are followed up at 14 days, 1 month, every 3 months for 2 years, every 6 months for 1 year, and then annually for 2 years.

Who is eligible to participate?

Inclusion Criteria: - Histological confirmation of HPV+ squamous cell carcinoma of the oropharynx. HPV positivity will be defined as positive staining for p16 on immunohistochemistry (IHC) - Gross total surgical resection with curative intent of the primary tumor and at least unilateral neck dissection within 7 weeks of registration - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 - Smoking history < 10 pack years - Absence of distant metastases on standard diagnostic work-up =< 8 weeks prior to registration; (chest computed tomography [CT], chest x-ray [CXR], positron emission tomography [PET]/CT, etc.) - Must have one of the following risk factors: - Lymph node > 3 cm - 2 or more positive lymph nodes - Perineural invasion - Lymphovascular space invasion - T3 or microscopic T4a primary disease - Lymph node extracapsular extension < 1 mm in greatest extent - Absolute neutrophil count (ANC) >= 1500/mm^3 - Platelet count >= 100,000/mm^3 - Hemoglobin >= 9.0 g/dL - Direct bilirubin within upper limit of normal (ULN) - Creatinine =< ULN x 1.5 - Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only - Ability to complete questionnaire(s) by themselves or with assistance - Provide informed written consent - Willingness to return to enrolling institution for follow-up (during the active monitoring phase of the study) Exclusion Criteria: - Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects: - Pregnant women - Nursing women - Men or women of childbearing potential who are unwilling to employ adequate contraception - Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens - Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm - Other active malignancy =< 5 years prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: if there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer - History of myocardial infarction =< 180 days prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias - Prior history of radiation therapy to the affected site - History of connective tissue disorders such as rheumatoid arthritis, lupus, or Sjogren's disease - Presence of any of the following risk factors after surgery: - Any positive surgical margin - Extracapsular extension >= 1 mm - Adenopathy below the clavicles - Prior systemic chemotherapy for the study cancer; NOTE: prior chemotherapy for a different cancer is allowable - History of allergic reaction to docetaxel - Receiving any medications or substances that are strong or moderate inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) - Use of strong or moderate inhibitors is prohibited =< 7 days prior to registration - Receiving any medications or substances that are inducers of CYP3A4 - Use of inducers is prohibited =< 12 days prior to registration

Last updated:
3/24/2014
NCT ID:
NCT01932697
IRB Number:
12-005272