Status:
COMPLETED
Combination Chemotherapy and Radiation in Treating Patients With Stage III or IV Head and Neck Cancer (Paradigm Trial)
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ther...
Detailed Description
OBJECTIVES: Primary * Compare 3-year survival of patients with previously untreated stage III or IV squamous cell carcinoma of the head and neck treated with induction chemotherapy comprising doceta...
Eligibility Criteria
Inclusion
- List of Inclusion Criteria:
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT00095875
Start Date
August 1 2004
End Date
April 1 2012
Last Update
November 19 2013
Active Locations (15)
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1
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0658
2
CCOP - Colorado Cancer Research Program
Denver, Colorado, United States, 80224
3
Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus
Boca Raton, Florida, United States, 33486
4
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322