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Home > "E" Clinical Trials Conditions > Erlotinib and Radiation Therapy With or Without Cisplatin in Treating Patients With Mouth or Throat Cancer  Erlotinib and Radiation Therapy With or Without Cisplatin in Treating Patients With Mouth or Throat Cancer
Erlotinib and Radiation Therapy With or Without Cisplatin in Treating Patients With Mouth or Throat Cancer
For Condition: stage 3 squamous cell carcinoma of the oropharynx,stage 4 squamous cell carcinoma of the oropharynx,stage 3 squamous cell carcinoma of the lip and oral cavity,stage 2 squamous cell carcinoma of the lip and oral cavity,stage 2 squamous cell carcinoma of the oropharynx,stage 4 squamous cell carcinoma of the lip and oral cavity
Status: Recruiting
Sponsor(s): Sidney Kimmel Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. 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 erlotinib with radiation therapy with or without cisplatin may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining erlotinib with radiation therapy with or without cisplatin in treating patients who have advanced mouth or throat cancer.
Details: OBJECTIVES: - Determine the maximum tolerated dose of erlotinib administered with radiotherapy with or without cisplatin in patients with stage II, III, or IV squamous cell carcinoma of the oral cavity or oropharynx. - Determine the safety of these regimens in these patients. - Determine biological markers of activity of erlotinib in tumor biopsy specimens from these patients before and after treatment with these regimens. - Determine the ability of fludeoxyglucose F 18 positron-emission tomography scan to demonstrate biological activity of erlotinib and predict clinical response in patients treated with these regimens. OUTLINE: This is a multicenter, dose-escalation study of erlotinib. Patients are assigned to 1 of 2 regimens according to disease stage. - Regimen A (patients with stage II [T2, N0] or III [T1-2, N1] disease): Patients receive oral erlotinib once daily. Beginning on day 15, patients also undergo radiotherapy once daily 5 days a week for 7 weeks. - Regimen B (patients with stage III [T3, N0-1] or IV [T1-4, N2-3, M0 or T4, N0-1, M0] disease): Patients receive oral erlotinib and radiotherapy as in regimen A. Patients also receive cisplatin IV over 20 minutes on each day of radiotherapy. Patients in both regimens may continue to receive erlotinib once daily for up to 2 years in the absence of disease progression or unacceptable toxicity. In both regimens, cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 30 days, and then every 3 months for up to 2 years. PROJECTED ACCRUAL: A total of 24-48 patients (12-24 per regimen) will be accrued for this study within 6-24 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed squamous cell carcinoma of the oral cavity (OC) or oropharynx (OP) - OC sites include: oral tongue, buccal mucosa, floor of mouth, retromolar trigone, alveolar ridge, hard palate, and mucosal lip - OP sites include: base of tongue, tonsil, soft palate, and oropharyngeal wall - Stage II (T2, N0) or III (T1-2, N1) (eligible for regimen A only) - Stage III (T3, N0-1) or IV (T1-4, N2-3, M0 or T4, N0-1, M0) (eligible for regimen B only) - Documentation of evaluable tumor within the past 4 weeks - Operable or inoperable tumors allowed - No known brain involvement - No prior head and neck malignancies PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy - At least 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 Hepatic - Bilirubin normal (unless due to hemolysis or Gilbert's syndrome) - AST/ALT no greater than 2.5 times upper limit of normal - aPTT/INR normal (correctable with vitamin K) Renal - Creatinine normal OR - Creatinine clearance at least 60 mL/min Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No untreated or new cardiac arrhythmia Ophthalmic - No abnormalities of the cornea (e.g., dry eye syndrome or Sjögren's syndrome) - No congenital abnormalities (e.g., Fuch's dystrophy) - No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose) - No abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test) Gastrointestinal - G-tube dependency allowed - No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation - No active peptic ulcer disease - No known malabsorption syndrome Other - No other concurrent uncontrolled illness that would preclude study participation - No ongoing or active infection - No uncontrolled diabetes mellitus - No psychiatric illness or social situation that would preclude study participation - No prior allergic reactions attributed to compounds of similar chemical or biological composition to erlotinib or other study agents - No significant traumatic injury within the past 28 days - No other malignancy within the past 3 years except completely resected basal cell skin cancer or carcinoma in situ of the cervix - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - No prior immunotherapy for this malignancy Chemotherapy - No prior chemotherapy for this malignancy Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy for this malignancy Surgery - No prior surgical procedures affecting absorption - At least 28 days since prior major surgery Other - No prior epidermal growth factor receptor-targeting therapies for this malignancy - No prior investigational agents for this malignancy - No other prior therapy for this malignancy - No concurrent commercial or other investigational anticancer agents or therapies - No concurrent combination antiretroviral therapy for HIV-positive patients - No concurrent warfarin
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MauraGillison, Study Chair, Sidney Kimmel Cancer Center
MBCCOP - LSU Health Sciences Center *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Jill Gilbert 504-568-5136
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231
United States
Recruiting Maura Gillison 410-502-7412
Additional Information:
Study ID Numbers: CDR0000257942; JHOC-20020723,NCI-5375
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00049166
Other Stage 3 Squamous Cell Carcinoma Of The Oropharynx Studies:
1. Amifostine to Treat Side Effects of Treatment in Patients Receiving Radiation Therapy and Cisplatin for Advanced Head and Neck Cancer
2. Docetaxel Plus Carboplatin in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
3. Chemotherapy With or Without Docetaxel Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
4. Radiation Therapy and Cisplatin in Treating Patients With Advanced Head and Neck Cancer
5. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer
Related Studies:
Other stage 3 squamous cell carcinoma of the oropharynx Clinical Trials
Other Louisiana Clinical Trials
Other New Orleans Clinical Trials
Erlotinib and Radiation Therapy With or Without Cisplatin in Treating Patients With Mouth or Throat Cancer
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