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A Phase II Study of CI-1033 in Treating Patients with Metastatic (Stage IV) Breast Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on A Phase II Study of CI-1033 in Treating Patients with Metastatic (Stage IV) Breast Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Phase II Study of CI-1033 in Treating Patients with Metastatic (Stage IV) Breast Cancer Clinical research trials and A Phase II Study of CI-1033 in Treating Patients with Metastatic (Stage IV) Breast Cancer healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as A Phase II Study of CI-1033 in Treating Patients with Metastatic (Stage IV) Breast Cancer. A Phase II Study of CI-1033 in Treating Patients with Metastatic (Stage IV) Breast Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a A Phase II Study of CI-1033 in Treating Patients with Metastatic (Stage IV) Breast Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their A Phase II Study of CI-1033 in Treating Patients with Metastatic (Stage IV) Breast Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Phase II Study of CI-1033 in Treating Patients with Metastatic (Stage IV) Breast Cancer  A Phase II Study of CI-1033 in Treating Patients with Metastatic (Stage IV) Breast Cancer
A Phase II Study of CI-1033 in Treating Patients with Metastatic (Stage IV) Breast Cancer
For Condition: Breast Cancer
Status: No longer recruiting
Sponsor(s): Pfizer ,
Synopsis: CI-1033 is an experimental drug that acts as an inhibitor of erbB (EGFR) receptors, which may be involved in tumor growth. The primary objective of this study is to assess the antitumor activity of CI-1033 in patients with metastatic breast cancer. Patients with histologically confirmed metastatic (Stage IV) breast cancer and who have received no more than 2 prior cytotoxic chemotherapy regimens are eligible for this study. CI-1033 is administered orally. Patients are required to have blood tests periodically while receiving treatment and will be closely monitored throughout the study for possible side effects and response to treatment. Patients may not have received any prior treatment with other agents that target erbB receptors, including Herceptin (trastuzumab) or Iressa (gefitinib).
Details:
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Female
Protocol Entry Criteria: - Female, at least 18 years of age - Histologically confirmed diagnosis of breast cancer - Metastatic (Stage IV) disease - Progressive or recurrent disease following the most recent therapy - No more than 2 different, prior cytotoxic chemotherapy regimens for metastatic disease - At least one measurable target lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) that has not been irradiated - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, determined within 2 weeks prior to randomization - Estimated life expectancy of > 12 weeks - Capable of giving written informed consent - Capable of swallowing intact CI-1033 capsules - Capable of understanding and adhering to the protocol requirements - No prior exposure to CI-1033 or other agents that target the erbB receptor family (such as Herceptin, Iressa, Tarceva, IMC-C225, and EKB-569) - No known hypersensitivity reaction to tyrosine kinase inhibitors - Adequate liver, renal, or bone marrow function determined within 2 weeks prior to randomization - No cytotoxic chemotherapy within 3 weeks prior to baseline disease assessments (6 weeks for nitrosoureas or mitomycin) - No immunotherapy (including Herceptin) or other biologic therapy within 2 weeks prior to baseline disease assessments - No hormone therapy (including hormone replacement therapy) within 4 weeks prior to baseline disease assessments (6 weeks for megestrol acetate) - Patients must have recovered from the acute effects of any radiation therapy or surgery - No treatment with any other investigational therapy within 4 weeks prior to baseline disease assessments - No history of any cancer other than the present condition (except nonmelanoma skin cancer or carcinoma in situ of the cervix) within the last 5 years - No patients with untreated brain metastases or patients that have not recovered from treatment for brain metastases - No known malabsorption syndrome or other condition that may impair absorption of study medication - No comorbidity or condition which compromises compliance with this protocol as judged by the investigator or that would significantly complicate interpretation of the safety profile of CI-1033 - No patients having reproductive potential who are not using a method of birth control or who are pregnant or breastfeeding or have a positive pregnancy test during baseline
Total Enrollment: 168
Location and Contact Information:
University of Chicago Medical Center
Chicago, Illinois, 60637
United States
Jules Bordet Institute
Brussels, , 1000
Belgium
University of Michigan Medical Center
Ann Arbor, Michigan, 48109-0922
United States
Hamilton regional Cancer Center
Hamilton, Ontario, L8V 5C2
Canada
Department of Medicine, Royal Marsden Hospital
London, , SW3 6JJ
United Kingdom
Hospital Charles-LeMoyne
Greenfield Park, Quebec, H3T 1E2
Canada
Manitoba Clinic
Winnipeg, Manitoba, R3A 1M3
Canada
Department of Medicine, Royal Marsden Hospital
Sutton, Surrey, SM2 SPT
United Kingdom
Jack D. Weiler Hospital of the Albert Einstein Cancer Center
Bronx, New York, 10461
United States
U2 Gasthuisberg Dept. Oncology
Levven, , B-3000
Belgium
Hopital Notre-Dame du CHUM
Montreal, Quebec, H2L 4M1
Canada
Clinique Sainte-Catherine
Avignon Cedex 2, , 84082
France
Henry Ford Health System, Josephine Ford Cancer Center
Detroit, Michigan, 48202-2689
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Sodersjukhuset Onkologkliniken
Stockholm, , 118 83
Sweden
Avdelningen för nuklearmedicin
Stockholm, , 17176
Sweden
Private Office
Arroyo Grande, California, 93420
United States
Department of Medical Oncology, Thomas Guy House, Guy's Hospital
London, , SE1 9RT
United Kingdom
Radiumhemmet kl. F. onkologi
Stockholm, ,
Sweden
University Hospitals of Cleveland
Cleveland, Ohio, 44106
United States
Hospital Universitario 12 de Octubre
Madrid, , 28041
Spain
Montgomery Cancer Center
Montgomery, Alabama, 36106
United States
St James's Hospital
Dublin 8, ,
Ireland
Complexe Hospitalier de la Sagamie, Unite de Recherche Clinique
Chicoutimi, Quebec, G7H 5H6
Canada
University College Hospital
Galway, ,
Ireland
Huntsman Cancer Center at the University of Utah
Salt Lake City, Utah, 84112-5550
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030
United States
Sarah Cannon Cancer Center
Nashville, Tennessee, 37203
United States
Ospedale Bellaria, U.O. di Oncologica Medica
Bologna, , 40139
Italy
Abramson Cancer Center at the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Institute for Drug Development Cancer Therapy and Research Center
San Antonio, Texas, 78229
United States
Institut Curie, Departement d-Oncologie Medicale
Paris Cedex 05, , 75248
France
Anschutz Cancer Pavilion
Aurora, Colorado, 80010
United States
University of Alabama at Birmingham
Birmingham, Alabama, 35294-3300
United States
Dipartimento Misto Di Oncologia Ed Ematologia - C.O.M. - Policlinico Di Modena
Modena, , 41100
Italy
University of California at San Francisco Comprehensive Cancer Center
San Francisco, California, 94115
United States
Texas Oncology, PA
Dallas, Texas, 75246
United States
Istituto Regina Elena
Roma, , 00144
Italy
Hospital de la Pitie Salpetriere, Service d'Oncologie Medicale
Paris Cedex 13, , 75651
France
Azienda Unita Sanitaria Locale Di Forli, Presidio Ospedaliero "G.B. Morgagni - L. Pierantoni"
Forli, , 47100
Italy
BC Cancer Agency
Vancouver, British Columbia, V5Z 4E6
Canada
Beatson Oncology Center Western Infirmary
Glascow, Scotland,
United Kingdom
Cancer Research Network, Inc
Plantation, Florida, 33324
United States
Mount Sinai Medical Center, Comprehensive Cancer Center
Miami, Florida, 33140
United States
Clinical Trials & Research Associates, Inc.
Montebello, California, 90640
United States
Servicio De Oncologia Medica Hospital Clinico San Carlos
Madrid, , 28040
Spain
Additional Information:
Study ID Numbers: 1033-011;
Study Start Date: January 2003
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00051051
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3. Celecoxib in Preventing Breast Cancer in At-Risk Premenopausal Women
4. Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Esophagus, Stomach, Small Intestine, or Colon
5. Tamoxifen for the Prevention of Breast Cancer in High-Risk Women
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A Phase II Study of CI-1033 in Treating Patients with Metastatic (Stage IV) Breast Cancer
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