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Adjuvant Erlotinib After Completing Chemoradiotherapy in Treating Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Adjuvant Erlotinib After Completing Chemoradiotherapy in Treating Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Adjuvant Erlotinib After Completing Chemoradiotherapy in Treating Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck Clinical research trials and Adjuvant Erlotinib After Completing Chemoradiotherapy in Treating Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Adjuvant Erlotinib After Completing Chemoradiotherapy in Treating Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck. Adjuvant Erlotinib After Completing Chemoradiotherapy in Treating Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Adjuvant Erlotinib After Completing Chemoradiotherapy in Treating Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck clinical trial. Human subjects often get the best healthcare possible for their Adjuvant Erlotinib After Completing Chemoradiotherapy in Treating Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > Adjuvant Erlotinib After Completing Chemoradiotherapy in Treating Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck  Adjuvant Erlotinib After Completing Chemoradiotherapy in Treating Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Adjuvant Erlotinib After Completing Chemoradiotherapy in Treating Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck
For Condition: Head and Neck Cancer
Status: Recruiting
Sponsor(s): National Cancer Institute of Canada ,
Synopsis: RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving erlotinib after chemoradiotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of adjuvant erlotinib after completing chemoradiotherapy in treating patients who have locally advancedsquamous cell carcinoma (cancer) of the head and neck.
Details: OBJECTIVES: Primary - Determine the recommended dose of adjuvant erlotinib after the completion of chemoradiotherapy in patients with stage III, IVA, or IVB squamous cell carcinoma of the head and neck. - Determine the toxicity of this drug in these patients. - Determine the effects of this drug on plasma and urinary angiogenic factors (specifically vascular endothelial growth factor receptor [VEGFR], VEGFR1, VEGFR2, and basic fibroblast growth factor levels) in these patients. - Compare the disease-free survival of patients treated with this drug after chemoradiotherapy vs historical control patients treated with chemoradiotherapy alone. - Correlate levels of angiogenic factors with initial blood vessel concentration in the tumor and the presence or absence of EGFRvIII mutation in patients treated with this drug. OUTLINE: This is an open-label, dose-escalation, multicenter study. Patients receive oral erlotinib once daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 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 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 8 patients are treated at that dose level. Patients are followed at 4 weeks, every 12 weeks for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 6-20 patients will be accrued for this study.
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 head and neck - Stage III, IVA, or IVB - Must have completed cisplatin- or carboplatin-based chemoradiotherapy within the past 4-12 weeks - Prior radiotherapy must have been given with a radical intent with receipt of at least 90% of planned dose - No evidence of disease or presence of inoperable minimal residual disease, defined by 1 of the following: - Complete response at primary tumor site and nodes (with or without nodal surgery after chemoradiotherapy) - Negative lymph node status (by physical or radiological exam) AND persistent tumefaction less than 25% of original tumor size or residual mass due to scarring - Tumor tissue samples available for EGFRvIII mutation analysis - No known brain metastasis PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - Not specified Hematopoietic - Absolute granulocyte count 1,500/mm^3 - Platelet count 100,000/mm^3 Hepatic - ALT/AST < 2 times upper limit of normal (ULN) - Bilirubin < ULN (unless due to Gilbert’s syndrome) Renal - Creatinine < 1.5 times ULN Cardiovascular - No myocardial infarction within the past year - No cardiac ventricular arrhythmias requiring medication - No history of cardiac disease - No uncontrolled high blood pressure - No unstable angina - No congestive heart failure Ophthalmic - No history of severe dry eye syndrome, Sjögren’s syndrome, or keratoconjunctivitis sicca - No severe exposure keratopathy - No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose) - No abnormal corneal sensitivity test (Schirmer test or similar tear production test) - No disorder that might increase the risk for epithelium-related complication (e.g., bullous keratopathy, aniridia, severe chemical burns, or neutrophilic keratitis) - No congenital abnormality (e.g., Fuch’s dystrophy) - No ocular inflammation or infection Gastrointestinal - Able to take oral medication - No gastrointestinal (GI) tract disease requiring IV alimentation - No uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis) - No active peptic ulcer disease Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No serious active infection - No other serious underlying medical condition that would preclude study participation - No prior allergic reaction to compounds of similar chemical or biological composition to erlotinib - No other malignancy with the past 5 years except adequately treated non-melanoma skin cancer (unless in the same area treated with radical radiotherapy) or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics - Recovered from prior chemotherapy Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - Recovered from prior radiotherapy Surgery - See Disease Characteristics - No prior surgical procedure affecting absorption - No concurrent ophthalmic surgery Other - More than 4 weeks since other prior investigational drugs - No other concurrent investigational agents - No other concurrent anticancer therapy - Concurrent oral anticoagulants (e.g., warfarin) allowed provided there is increased vigilance with respect to INR - Concurrent nasogastric or gastrostomy tube feeding for dysphagia allowed provided there is no evidence of significant residual mucositis (i.e., > grade 1)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DenisSoulieres, Study Chair, Centre Hospitalier de l'Universite de Montreal
Centre Hospitalier de l'Universite de Montreal *Recruiting*
Montreal, Quebec, H2L-4M1
Canada
Recruiting Denis Soulieres 514-890-8200 ext. 27066
Additional Information:
Study ID Numbers: CDR0000353485; CAN-NCIC-HN5,ROCHE-CAN-NCIC-HN5
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00079053
Other Head And Neck Cancer Studies:
1. Gene Therapy in Treating Patients With Advanced Head and Neck Cancer
2. Sargramostim in Decreasing Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer
3. Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer, Ovarian Cancer, or Head and Neck Cancer
4. Photodynamic Therapy System for Patients with Refractory/Unresponsive Solid Tumors
5. Study of SCH 54031 in Surgically Resectable Squamous Cell Tumors of the Head and Neck
Related Studies:
Other Head and Neck Cancer Clinical Trials
Other Quebec Clinical Trials
Other Montreal Clinical Trials
Adjuvant Erlotinib After Completing Chemoradiotherapy in Treating Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck
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