Status:
COMPLETED
Cisplatin, Fluorouracil, Iressa, and Radiation Therapy Patients With Locally Advanced Head and Neck Cancer
Lead Sponsor:
David Adelstein
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as 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. Gefi...
Detailed Description
OBJECTIVES: Primary * Explore the activity of cisplatin, fluorouracil, gefitinib, and hyperfractionated radiotherapy, in terms of 1-year survival and 1-year distant metastatic disease control, in pa...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed primary\* squamous cell carcinoma of the head and neck region, excluding any of the following:
- Nasopharynx
- Paranasal sinuses
- Salivary glands NOTE: \*Primary site must be identified
- Locoregionally confined stage III or IV disease
- No evidence of nodal disease below the clavicles
- No distant hematogenous metastases (M0)
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- WBC \> 3,500/mm³
- Platelet count \> 100,000/mm³
- Creatinine ≤ 2.0 mg/dL
- Alkaline phosphatase \< 2 times normal
- AST \< 2 times normal
- Bilirubin ≤ 2.0 mg/dL
- Calcium normal
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Must not be a poor compliance risk for follow-up
- No known severe hypersensitivity to gefitinib or any excipients of this drug
- No evidence of clinically active interstitial lung disease
- Patients with chronic, stable radiographic changes who are asymptomatic are eligible
- No unstable or uncontrolled angina, clinically apparent jaundice, or active infection
- No history of any other malignancy (except squamous cell or basal cell skin cancer or cervical carcinoma in situ) unless disease free for ≥ 5 years
- No other severe, uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
- PRIOR CONCURRENT THERAPY:
- Recovered from prior oncologic or other major surgery
- No prior definitive surgery, radiotherapy, chemotherapy, immunotherapy, or epidermal growth factor receptor inhibitors for head and neck cancer
- No investigational drugs within the past 30 days
- No concurrent CYP3A4 inducers, including any of the following:
- Phenytoin
- Carbamazepine
- Rifampin
- Phenobarbital
- Hypericum perforatum (St. John's wort)
- Concurrent surgery allowed provided gefitinib is not administered 2 weeks before and 2 weeks after surgery
- No concurrent aminoglycoside antibiotics
Exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00352105
Start Date
April 1 2006
End Date
May 1 2010
Last Update
November 5 2012
Active Locations (1)
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1
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195