|
OSI-774 to Treat Advanced Breast Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on OSI-774 to Treat Advanced Breast Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. OSI-774 to Treat Advanced Breast Cancer Clinical research trials and OSI-774 to Treat Advanced Breast Cancer medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like OSI-774 to Treat Advanced Breast Cancer. OSI-774 to Treat Advanced Breast Cancer Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a OSI-774 to Treat Advanced Breast Cancer clinical trial. Participants frequently obtain the most expert healthcare available for their OSI-774 to Treat Advanced Breast Cancer condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "O" Clinical Trials Conditions > OSI-774 to Treat Advanced Breast Cancer  OSI-774 to Treat Advanced Breast Cancer
OSI-774 to Treat Advanced Breast Cancer
For Condition: Breast Neoplasms
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will examine the role of an experimental cancer drug, OSI-774, in breast cancer treatment. OSI-774 blocks the activity of a protein called epidermal growth factor receptor (EGFR) that cancer cells need to grow. It has shrunk tumors in some patients with lung, ovary, and head and neck cancer, but its effects in breast cancer patients are unknown. This study will focus on how OSI-774 interferes with EGFR and related proteins involved in communication between tumor cells. Patients 18 years of age and older with advanced breast cancer that has not been controlled with standard treatments may be eligible for this study. Candidates will be screened with a medical history and physical examination, blood tests, chest X-ray, computed tomography (CT) of the head and abdomen, bone scan, MUGA (heart scan), and possibly CT scans of the chest and pelvis, if medically warranted. Patients must have a tumor that is accessible for serial biopsies (surgical removal of a tissue sample). Participants will take OSI-774 by mouth every day in 28-day treatment cycles. They will keep a diary of when they take the drug, side effects they experience, and how long the side effects last. They will come to the Clinical Center every 28 days for a physical examination and blood tests. In addition, they will have the following tests: - Blood tests - In addition to the blood tests at the start of each treatment cycle, blood will be drawn at certain other times to determine blood levels of OSI-774 and the amount of a protein that attaches to the drug. - Biopsies - Small tissue samples from the tumor, the skin and inside the cheek near a third molar (wisdom tooth) will be taken at the start of the study and after about 28 days of treatment. The samples will be surgically removed after the area is numbed with a local anesthetic. - Positron emission tomography (PET) scan - PET scans will be done before treatment starts and after about 28 days of treatment. For this test, the patient lies on a table that is positioned partly inside the PET scanner (a doughnut-shaped machine) and is given an injection of a glucose solution called fluorodeoxyglucose (FDG). FDG consists of glucose molecules labeled with a radioactive material called fluorine-18. A special camera detects the radiation emitted by the FDG and produces images that show how much glucose is being used in various parts of the body. This test can detect cancer, because tumor cells use much more energy than normal cells and therefore take up more glucose as fuel. - Scans and X-rays - Some imaging studies are done before starting treatment, some at every 3 treatment cycles (12 weeks) and some at the end of the study. These tests include chest X-ray, CT scans of the head and abdomen, and possibly chest and pelvis, bone scan, MUGA scan and, if needed, regular X-rays of bones. Other scans may also be done as needed. - Electrocardiogram - An EKG (recording of the electrical activity of the heart) is done before treatment begins. - Eye exams will be performed if there are vision changes or at the doctor's discretion.
Details: Breast cancer is associated with aberrant or overexpression of epidermal growth factor receptor (EGFR). Overexpression of EGFR is found in approximately 45% of breast cancers and is associated with disease progression and reduced survival, thus making it an ideal disease for treatment with EGFR-targeted therapy. The purpose of this study is to evaluate signal transduction parameters before and after treatment with OSI-774, an oral EGFR-tyrosine kinase inhibitor, in patients with locally advanced or metastatic breast cancer, in an attempt to validate these biologic endpoints. Changes in EGFR phosphorylation will be assessed at baseline and approximately after 1 month of therapy by obtaining serial tumor biopsies. Proteins downstream from EGFR, namely ERK and AKT, will be assessed as potential markers of EGFR-tyrosine kinase inhibition. Pharmacokinetics will be obtained to correlate effect in tumor biopsy with dose and drug concentration. Additional biologic assays include measurement of EGFR and EGFR-dependent molecules via proteomic arrays. Serial skin and buccal biopsies will be obtained to determine if this is a potential surrogate tissue to monitor inhibition of EGFR signaling molecules. Also, fluorine-18-fluorodeoxyglucose (FDG)-positron emission tomography (PET) will be performed to assess the ability to measure changes in tumor metabolism.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Patients must have histologically confirmed adenocarcinoma of the breast. Patients must have incurable, locally advanced or metastatic breast cancer. Patients must have tumor accessible for serial biopsies. Patients must be greater than or equal to 18 years of age. Patients must have an ECOG performance status of 0, 1, or 2. Patients must have a life expectancy of 3 months or longer. Patients of childbearing potential must be willing to use an effective means of contraception during their participation on trial. Patients must have adequate bone marrow and organ function defined by the following: Granulocyte count greater than or equal to1500/microL; Platelet count greater than or equal to 100,000/microL; Total bilirubin within normal institutional limits; ALT/SGPT and AST/SGOT less than or equal to 2.5x institutional; upper limit of normal (ULN); Creatinine within normal institutional limits or if above institutional ULN, measured creatinine clearance greater than or equal to 60 ml/min. Patients with no currently active brain metastasis who are neurologically stable and corticosteroids have been discontinued for greater than or equal to 4 weeks prior to entering the study. Patients must be willing to comply with on-study and follow-up procedures, e.g. tumor, skin, and buccal biopsies and FDG-PET scans. Patients must be able to sign a written informed consent. Patients must have a left ventricular ejection fraction of greater than or equal to 40% without clinical signs or symptoms of heart failure. EXCLUSION CRITERIA: Patients who have had chemotherapy or radiotherapy less than 3 weeks (less than 6 weeks for nitrosureas or mitomycin C) or hormonal therapy less than 2 weeks prior to entering the study. Patients with symptomatic or untreated brain metastases or carcinomatous meningitis. Patients who are on concurrent investigational agent(s). Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to OSI-774, such as ZD1839 or other anilinoquinazolines. Patients with uncontrolled intercurrent illness including active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled diabetes mellitus, psychiatric illness or social situation that would limit compliance with study requirements. Patients who are pregnant or lactating. Patients with a history of other primary malignancies except for in situ carcinoma of the cervix, non-melanomatous skin cancers, or previous breast cancer in the last 5 years prior to on-study date. Patients with abnormalities of the cornea based on history (e.g., dry eye syndrome, Sjogren's syndrome), congenital abnormality (e.g., Fuch's dystrophy), abnormal slit-lamp examination using a vital dye (e.g., fluorescein, Bengal-Rose), and/or abnormal corneal sensitivity test (Schirmer test or similar tear production test). Patients who are concurrently using contact lenses. Patients who weigh greater than or equal to 136 kg (weight limit for the PET scanner table). Patients who have life-threatening disease and no previous treatment.
Total Enrollment: 20
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 020061; 02-C-0061
Study Start Date: November 28, 2001
Record last reviewed: April 18, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00027313
Other Breast Neoplasms Studies:
1. A Phase II Study of a Combination of MTA (LY231514) and Gemcitabine in Patients with Metastatic Breast Cancer.
2. Safety Study of hMN14 to Treat Either Colorectal or Breast Cancer
3. Safety and efficacy study of the combination of CpG 7909 and Herceptin in patients with metastatic breast cancer
4. Zometa - Femara Adjuvant Synergy Trial (ZFAST) - Cancer Treatment Related Bone Loss in Postmenopausal Women with Estrogen Receptor Positive and/or Progesterone Receptor Positive Breast Cancer Receiving Adjuvant Hormonal Therapy
5. Evaluation of Breast Cancer Recurrence Rates Following Surgery for Ductal Carcinoma In Situ
Related Studies:
Other Breast Neoplasms Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
OSI-774 to Treat Advanced Breast Cancer
|
|
|
|
|
|
|
|
