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Gefitinib in Treating Patients With Metastatic or Unresectable Head and Neck Cancer or Non-Small Cell Lung Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Gefitinib in Treating Patients With Metastatic or Unresectable Head and Neck Cancer or Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Gefitinib in Treating Patients With Metastatic or Unresectable Head and Neck Cancer or Non-Small Cell Lung Cancer Clinical research trials and Gefitinib in Treating Patients With Metastatic or Unresectable Head and Neck Cancer or Non-Small Cell Lung Cancer health trials occur in many 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 effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Gefitinib in Treating Patients With Metastatic or Unresectable Head and Neck Cancer or Non-Small Cell Lung Cancer. Gefitinib in Treating Patients With Metastatic or Unresectable Head and Neck Cancer or Non-Small Cell Lung Cancer Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Gefitinib in Treating Patients With Metastatic or Unresectable Head and Neck Cancer or Non-Small Cell Lung Cancer clinical trial. Test subjects typically receive the most expert healthcare available for their Gefitinib in Treating Patients With Metastatic or Unresectable Head and Neck Cancer or Non-Small Cell Lung Cancer condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "G" Clinical Trials Conditions > Gefitinib in Treating Patients With Metastatic or Unresectable Head and Neck Cancer or Non-Small Cell Lung Cancer  Gefitinib in Treating Patients With Metastatic or Unresectable Head and Neck Cancer or Non-Small Cell Lung Cancer
Gefitinib in Treating Patients With Metastatic or Unresectable Head and Neck Cancer or Non-Small Cell Lung Cancer
For Condition: Head and Neck Cancer,thorax and respiratory cancer
Status: Recruiting
Sponsor(s): Southwest Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Gefitinib 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 gefitinib in treating patients who have metastatic or unresectablehead and neck cancer or non-small cell lung cancer.
Details: OBJECTIVES: - Determine the feasibility of a structured pilot study that includes pharmacokinetic sampling in patients age 75 and over or age 50 and under with metastatic or unresectable head and neck cancer or non-small lung cancer treated with gefitinib. - Compare, preliminarily, the peak concentration level, elimination half-life, and steady state level of gefitinib between patients in these two age groups. OUTLINE: This is a pilot, multicenter study. Patients are stratified according to age (75 years and over vs 50 years and under) Patients receive oral gefitinib on day 1 and then daily beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for up to 3 years after study registration. PROJECTED ACCRUAL: A total of 40 patients (20 per stratum) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed head and neck carcinoma or non-small cell lung cancer - Metastatic or unresectable disease for which standard curative or palliative treatment measures do not exist or are no longer effective - Previously treated with at least 1 and no more than 3 prior chemotherapeutic regimens, including prior adjuvant chemotherapy if completed within the past year - No known brain metastases PATIENT CHARACTERISTICS: Age - 50 and under or 75 and over Performance status - Zubrod 0-2 Life expectancy - Not specified Hematopoietic - Absolute granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than upper limit of normal (ULN) - SGOT or SGPT no greater than ULN - Alkaline phosphatase no greater than ULN Renal - Creatinine no greater than ULN Cardiovascular - No severe unstable or uncompensated cardiac disease Pulmonary - No severe unstable or uncompensated respiratory disease Other - Not pregnant or nursing - Fertile patients must use effective contraception - No other concurrent severe or uncontrolled systemic disease or infection - Able to swallow oral medication in pill form PRIOR CONCURRENT THERAPY: Biologic therapy - No prior epidermal growth factor receptor inhibitors - No concurrent immunotherapy for the malignancy Chemotherapy - See Disease Characteristics - No concurrent chemotherapy Endocrine therapy - No concurrent hormonal therapy Radiotherapy - No concurrent radiotherapy Surgery - Not specified Other - No concurrent agents that induce CYP3A4, including the following: - Nafcillin - Rifampin - Carbamazepine - Phenobarbital - Phenytoin - Oxcarbazepine - Fosphenytoin - Primidone - St. John's wort - Rifabutin - Rifapentine - Modafinil - No concurrent retroviral therapies for HIV-positive patients - Recovered from prior therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KimMargolin, , Beckman Research Institute
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4095
United States
Recruiting Scott Lippman 713-745-3672
Barbara Ann Karmanos Cancer Institute *Recruiting*
Detroit, Michigan, 48201-1379
United States
Recruiting Lawrence Flaherty 313-745-9155
City of Hope Comprehensive Cancer Center *Recruiting*
Duarte, California, 91010-0269
United States
Recruiting Kim Margolin 626-359-8111
Veterans Affairs Medical Center - Biloxi *Recruiting*
Biloxi, Mississippi, 39531-2410
United States
Recruiting Robert Veith 504-568-5151
University of Texas Health Science Center at San Antonio *Recruiting*
San Antonio, Texas, 78229-3900
United States
Recruiting Geoffrey Weiss 210-617-5120
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus *Recruiting*
Seattle, Washington, 98104
United States
Recruiting Saul Rivkin 206-386-2441
Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland, Ohio, 44195-9001
United States
Recruiting George Budd 216-444-6480
University of Colorado Cancer Center at University of Colorado Health Sciences Center *Recruiting*
Aurora, Colorado, 80010
United States
Recruiting Anthony Elias 720-848-1622
Kansas Cancer Institute at the University of Kansas Medical Center *Recruiting*
Kansas City, Kansas, 66160-7353
United States
Recruiting Sarah Taylor 913-588-6029
University of California Davis Cancer Center *Recruiting*
Sacramento, California, 95817
United States
Recruiting Angela Davies 916-734-3771
USC/Norris Comprehensive Cancer Center and Hospital *Recruiting*
Los Angeles, California, 90033
United States
Recruiting Heinz-Josef Lenz 323-865-3955
Cardinal Bernardin Cancer Center at Loyola University Medical Center *Recruiting*
Maywood, Illinois, 60153-5500
United States
Recruiting Patrick Stiff 708-327-3148
Additional Information:
Study ID Numbers: CDR0000322890; SWOG-S0322
Study Start Date:
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00068497
Other Head And Neck Cancer Studies:
1. Iseganan Hydrochloride in Preventing Oral Mucositis in Patients Who Are Undergoing Radiation Therapy for Head and Neck Cancer
2. ONYX-015 With Cisplatin and Fluorouracil in Treating Patients With Advanced Head and Neck Cancer
3. Bevacizumab and Erlotinib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
4. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced and/or Recurrent Head and Neck Cancer
5. Perifosine in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Related Studies:
Other Head and Neck Cancer Clinical Trials
Other Texas Clinical Trials
Other San Antonio Clinical Trials
Gefitinib in Treating Patients With Metastatic or Unresectable Head and Neck Cancer or Non-Small Cell Lung Cancer
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