Expired Study
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Newark, New Jersey 07101


The purpose of this study is to compare two different types of treatments for your type of cancer. The first treatment is called induction chemotherapy. Patients who receive Induction chemotherapy are treated with the chemotherapy drugs Docetaxel (Taxotere®), Cisplatin, and 5-Fluorouracil (5-FU) (otherwise known as "TPF"). TPF has shown positive responses when treating head and neck cancer. TPF is followed by chemotherapy treatments with Docetaxel or Carboplatin once a week and daily radiation treatments. This is called chemoradiotherapy. The second type of treatment, patients receive chemoradiotherapy with Cisplatin and daily radiation has shown to be useful in treating cancers like yours. The comparison between the two types of treatments has not been done. Researchers do not know which of the two treatments is better to treat your type of cancer. This study will evaluate which treatment may be more effective and to compare the different side effects that may be experienced.


DISEASE CHARACTERISTICS: Histologically or cytologically confirmed squamous cell carcinoma of the head and neck Stage III or IV* disease One of the following primary tumor sites: Oral cavity No mandible invasion Oropharynx Hypopharynx Larynx The following primary tumor sites are excluded: Nasal cavity Paranasal cavity Nasopharynx NOTE: *No evidence of distant metastases by chest x-ray, abdominal ultrasound, or CT scan (for patients with liver function test abnormalities) or bone scan (for patients with local symptoms) At least 1 uni- or bi-dimensionally measurable lesion PATIENT CHARACTERISTICS: Age Over 18 Performance status WHO 0-1 Life expectancy Not specified Hematopoietic Neutrophil count > 1,500/mm^3 Platelet count > 100,000/mm^3 Hemoglobin > 10 g/dL Hepatic Bilirubin normal AST or ALT within eligibility range Alkaline phosphatase within eligibility range Renal Creatinine clearance > 60 mL/min Cardiovascular No unstable cardiac disease despite treatment No myocardial infarction within the past 6 months Pulmonary No chronic obstructive pulmonary disease, defined as requiring hospitalization for pneumonia or respiratory decompensation within the past year Obstruction caused by the tumor allowed Neurologic No symptomatic peripheral neuropathy > grade 2 No symptomatic altered hearing > grade 2 No history of significant neurologic or psychiatric disorders, including dementia or seizures Other No active drug addiction, including alcohol, cocaine, or intravenous drugs within the past 6 months No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, or other cancer curatively treated by surgery alone No active, clinically significant, uncontrolled infection No autoimmune disease requiring therapy No unhealed or clinically active peptic ulcer disease No hypercalcemia No other serious illness or medical condition No involuntary weight loss > 25% of body weight within the past 2 months HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for at least 3 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy Endocrine therapy Not specified Radiotherapy No prior radiotherapy Surgery No prior organ transplantation No prior surgery for this cancer Biopsy allowed Other More than 30 days since prior participation in another investigational study No other concurrent anticancer therapy



Primary Contact:

Principal Investigator
Robert I. Haddad, MD
Dana-Farber Cancer Institute

Backup Contact:


Location Contact:

Newark, New Jersey 07101
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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