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Home > "G" Clinical Trials Conditions > Gefitinib and Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III or Stage IV Head and Neck Cancer  Gefitinib and Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III or Stage IV Head and Neck Cancer
Gefitinib and Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III or Stage IV Head and Neck Cancer
For Condition: Hypopharyngeal Cancer,Oropharyngeal Cancer,Laryngeal Cancer,lip and oral cavity cancer
Status: Recruiting
Sponsor(s): University of Colorado Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Biological therapies such as gefitinib may interfere with the growth of tumor cells and slow the growth of cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining gefitinib and radiation therapy with cisplatin may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining gefitinib and radiation therapy with or without cisplatin in treating patients who have stage III or stage IV head and neck cancer.
Details: OBJECTIVES: - Determine the maximum tolerated dose of gefitinib in combination with radiotherapy with or without cisplatin in patients with previously untreated, locally advanced squamous cell carcinoma of the head and neck. - Determine the dose-dependent local and/or systemic toxic effects of these regimens in these patients. - Determine the feasibility and toxicity profile of protracted continuous daily dosing of gefitinib after completion of radiotherapy in these patients. - Determine the response rate, relapse-free survival rate, and overall survival rate in patients treated with these regimens. OUTLINE: This is a multicenter, dose-escalation study of gefitinib. All patients receive oral gefitinib once daily beginning at least 7 days before and continuing throughout radiotherapy or chemoradiotherapy in the absence of disease progression or unacceptable toxicity. Patients are entered into 1 of 5 levels. - Level I: Patients undergo concurrent boost radiotherapy 5 days per week comprising once daily radiotherapy for 3.5 weeks followed by twice daily radiotherapy for 2.5 weeks. - Level II: Patients receive escalated dose of gefitinib and undergo radiotherapy as in level I. - Level III: Patients receive original dose of gefitinib, undergo standard fractionation radiotherapy comprising once daily radiotherapy 5 days per week for 7 weeks, and receive cisplatin IV over 30-60 minutes at the beginning of each week of radiotherapy. - Level IV: Patients receive escalated dose of gefitinib as in level II and undergo radiotherapy and chemotherapy as in level III. - Level V: Patients receive the maximum tolerated dose (MTD) of gefitinib, radiotherapy as in level I, and chemotherapy as in level III. Patients with clinical or radiologic evidence of residual disease are required to undergo neck dissection approximately 8 weeks after completion of radiotherapy or chemoradiotherapy. Patients resume oral gefitinib daily beginning 8 weeks after the completion of radiotherapy or chemoradiotherapy (12 weeks for patients who undergo neck dissection) and continuing for 2 years in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients are enrolled sequentially beginning at level I until the MTD of gefitinib is determined. The MTD is the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Twelve additional patients receive the MTD of gefitinib in combination with radiotherapy with or without cisplatin. Patients are followed every 6 months for 3 years. PROJECTED ACCRUAL: A total of 18-30 patients will be accrued for this study within 16 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed locally advanced squamous cell carcinoma of the head and neck involving the oral cavity, oropharynx, hypopharynx, or supraglottic or glottic larynx - Stage III or IV - No distant metastases - Only patients with intermediate stage disease (T1-2, N1-N2a or T3, N0-1) are eligible for radiotherapy alone with gefitinib PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy: - More than 6 months Hematopoietic: - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9 g/dL Hepatic: - Bilirubin normal - AST and ALT no greater than 2.5 times upper limit of normal Renal: - Creatinine normal OR - Creatinine clearance at least 60 mL/min Cardiac: - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Medically suitable to withstand a course of definitive radiotherapy - No ongoing or active infection - No other malignancy within the past 3 years except basal cell skin cancer or carcinoma in situ of the cervix - No prior allergic reactions to compounds of similar chemical or biological composition to gefitinib or other study agents - No uncontrolled concurrent medical or psychiatric illness or social situation that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior monoclonal antibodies with potential epidermal growth factor receptor (EGFR) binding therapy Chemotherapy: - No prior chemotherapy for head and neck cancer Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy to the head and neck region Surgery: - No prior surgery to the head and neck region except biopsy Other: - No prior anti-EGFR therapy including prior tyrosine kinase inhibitors - No concurrent combination anti-retroviral therapy for HIV-positive patients - No other concurrent investigational agents - No other concurrent commercial or investigational agents or therapies intended to treat the malignancy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidRaben, Study Chair, University of Colorado Cancer Center
St. Luke's-Roosevelt Hospital Center - St. Luke's Division *Recruiting*
New York City, New York, 10025
United States
Recruiting Kenneth Hu 212-523-5419
Monmouth Medical Center *Recruiting*
Long Branch, New Jersey, 07740-6395
United States
Recruiting Smitha Gollamudi 732-923-6890
University of Colorado Cancer Center at University of Colorado Health Sciences Center *Recruiting*
Aurora, Colorado, 80010-0510
United States
Recruiting David Raben 720-848-0100
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104-4283
United States
Recruiting Harry Quon 215-614-0392
Additional Information:
Study ID Numbers: CDR0000069284; UCHSC-01460,NCI-4551
Study Start Date:
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00033449
Other Lip And Oral Cavity Cancer Studies:
1. Gene Therapy in Treating Patients With Advanced Head and Neck Cancer
2. Surgery and Radiation Therapy Compared With Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer That Can Be Removed During Surgery
3. Paclitaxel and Cisplatin Plus Radiation Therapy Followed by Filgrastim in Treating Patients With Recurrent Head and Neck Cancer or Lung Cancer
4. Zileuton in Preventing Lung Cancer in Patients With Bronchial Dysplasia
5. Gene Therapy in Preventing Cancer in Patients With Premalignant Carcinoma of the Oral Cavity or Pharynx
Related Studies:
Other lip and oral cavity cancer Clinical Trials
Other New Jersey Clinical Trials
Other Long Branch Clinical Trials
Gefitinib and Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III or Stage IV Head and Neck Cancer
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