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Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer, Ovarian Cancer, or Head and Neck Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer, Ovarian Cancer, or Head and Neck Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer, Ovarian Cancer, or Head and Neck Cancer Clinical research trials and Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer, Ovarian Cancer, or Head and Neck Cancer healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer, Ovarian Cancer, or Head and Neck Cancer. Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer, Ovarian Cancer, or Head and Neck Cancer Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer, Ovarian Cancer, or Head and Neck Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer, Ovarian Cancer, or Head and Neck Cancer condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer, Ovarian Cancer, or Head and Neck Cancer  Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer, Ovarian Cancer, or Head and Neck Cancer
Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer, Ovarian Cancer, or Head and Neck Cancer
For Condition: Drug Toxicity,female reproductive cancer,Head and Neck Cancer,thorax and respiratory cancer
Status: Recruiting
Sponsor(s): University of Chicago Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Erlotinib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Phase I trial to study the effectiveness of erlotinib in treating patients who have metastatic or unresectablenon-small cell lung cancer, ovarian cancer, or head and neck cancer.
Details: OBJECTIVES: - Correlate the length of the CA dinucleotide repeat polymorphism in the epidermal growth factor receptor (EGFR) gene with observed toxicity in patients with advanced non-small cell lung cancer, ovarian cancer, or squamous cell carcinoma of the head and neck treated with erlotinib. - Determine the pharmacodynamic effects of this drug on EGFR activity and MAP kinase signaling in these patients. - Correlate toxicity and inhibition of EGFR phosphorylation with the area under the curve in patients treated with this drug. - Determine the observed antitumor response in patients treated with this drug. - Determine the toxic effects of this drug in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to length of CA dinucleotide repeat polymorphism (short vs medium vs long). Patients receive oral erlotinib on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 20 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - One of the following histologically or cytologically confirmed malignancies: - Non-small cell lung cancer - Ovarian cancer - Squamous cell carcinoma of the head and neck - Metastatic or unresectable disease - Measurable or evaluable disease - No uncontrolled brain metastases - Previously treated brain metastases allowed provided neurologic status has been stable for at least 4 weeks after therapy and there is no neurologic dysfunction that would confound evaluation of adverse events PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy - More than 12 weeks 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 Renal - Creatinine normal OR - Creatinine clearance at least 60 mL/min Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Ophthalmic - No significant ophthalmologic abnormalities*, including: - Severe dry eye syndrome - Keratoconjunctivitis sicca - Sjögren's syndrome - Severe exposure keratopathy - Disorders that increase the risk for epithelium-related complications, including any of the following: - Bullous keratopathy - Aniridia - Severe chemical burns - Neutrophilic keratitis NOTE: *Patients with mild forms of the listed conditions, an asymptomatic history, or normal ophthalmologic exam may be eligible at the discretion of the investigator Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior allergic reaction attributed to compounds of similar chemical or biological composition to erlotinib - No significant traumatic injury within the past 14 days - No other uncontrolled illness that would preclude study participation - No ongoing or active infection - No psychiatric illness or social situation that would preclude study compliance - No serious nonhealing wound ulcer or bone fracture PRIOR CONCURRENT THERAPY: Biologic therapy - At least 4 weeks since prior biologic therapy Chemotherapy - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) - No concurrent chemotherapy Endocrine therapy - Not specified Radiotherapy - At least 4 weeks since prior radiotherapy - No concurrent radiotherapy Surgery - More than 14 days since prior major surgery or open biopsy Other - Recovered from all prior therapy - At least 4 weeks since other prior investigational therapy - No prior small molecule epidermal growth factor receptor inhibitors, including erlotinib and gefitinib - No other concurrent therapy for the malignancy - No other concurrent investigational agents - No concurrent combination antiretroviral therapy for HIV-positive patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CharlesRudin, Study Chair, University of Chicago Cancer Research Center
University of Chicago Cancer Research Center *Recruiting*
Chicago, Illinois, 60637
United States
Recruiting Charles Rudin 773-702-4142
Additional Information:
Study ID Numbers: CDR0000304628; NCI-5948,UCCRC-12202A
Study Start Date:
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00063895
Other Thorax And Respiratory Cancer Studies:
1. Docetaxel and Cisplatin With or Without Dimesna in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
2. Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer, Ovarian Cancer, or Head and Neck Cancer
3. Chemotherapy, Amifostine, and Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer
4. Combination Chemotherapy Plus Amifostine in Treating Children With Malignant Germ Cell Tumors
5. Combination Chemotherapy After Surgery With or Without Chinese Herbal Therapy to Treat Symptoms in Women With Breast Cancer
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Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer, Ovarian Cancer, or Head and Neck Cancer
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