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Clinical Trial Title
Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer (Paradigm Trial)
Location and Contact Information
Rebecca and John Moores UCSD Cancer Center
La Jolla
Clinical Trials Office - Rebecca and John Moores UCSD Cancer 858-822-5354
cancercto@ucsd.edu
Status Recruiting
Sponsors
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Purpose
RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, fluorouracil, and
carboplatin, work in different ways to stop tumor cells from dividing so they stop growing
or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining
chemotherapy with radiation therapy may kill more tumor cells. It is not yet known which
regimen of chemotherapy and radiation therapy is most effective in treating head and neck
cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens
of chemotherapy and radiation therapy in treating patients who have stage III or stage IV
head and neck cancer.
Study Design: Treatment, Randomized, Active Control
Eligibility
Genders Eligible for Study: Both
Ages eligible for study: 18 Years to N/A
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
More Information
Study ID numbers:
CDR0000393548
DFCI-04006
AVENTIS-DFCI-04006
ClinicalTrials Identifier - NCT00095875
For additional information, visit ClinicalTrials.gov.
Information obtained from ClinicalTrials.gov on 11/23/2009
This directory includes clinical trials that involve researchers at UCSD Medical
Center. The information was obtained from ClinicalTrials.gov, a database of the
U.S. National Institutes of Health.
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