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A phase II study of cetuximab in patients who have stage IV colorectal cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about A phase II study of cetuximab in patients who have stage IV colorectal cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A phase II study of cetuximab in patients who have stage IV colorectal cancer Clinical research trials and A phase II study of cetuximab in patients who have stage IV colorectal cancer medical trials take place in many of places 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 usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like A phase II study of cetuximab in patients who have stage IV colorectal cancer. A phase II study of cetuximab in patients who have stage IV colorectal cancer Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a A phase II study of cetuximab in patients who have stage IV colorectal cancer clinical trial. Test subjects typically obtain the finest healthcare available for their A phase II study of cetuximab in patients who have stage IV colorectal cancer condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A phase II study of cetuximab in patients who have stage IV colorectal cancer  A phase II study of cetuximab in patients who have stage IV colorectal cancer
A phase II study of cetuximab in patients who have stage IV colorectal cancer
For Condition: Colorectal Neoplasms
Status: No longer recruiting
Sponsor(s): ImClone Systems , Bristol-Myers Squibb
Synopsis: The purpose of this clinical research study is to learn about the safety of cetuximab in patients with stage IV colorectal cancer, and who may benefit from cetuximab.
Details:
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Subjects must have signed an approved informed consent prior to any study procedures. - Subjects with histologically or pathologically confirmed metastatic colorectal cancer, which is EGFR-positive by IHC (may be based on archival samples) - Subjects with ECOG performance status 0, 1 or 2. - Subjects who have failed, either due to lack of efficacy or due to intolerance, all available chemotherapy for the treatment of metastatic colorectal cancer. - Subjects who have failed to meet eligibility criteria for any other existing cetuximab trial. - Subjects must have received at least two chemotherapy regimens for metastatic disease OR adjuvant therapy plus one chemotherapy regimen for metastatic disease, provided the subject progressed within 6 months of completing their adjuvant therapy. - Prior chemotherapy must have included all of the follow drugs: irinotecan, oxaliplatin, and a fluoropyrimidine. - Subjects adequately recovered from any recent surgery, radiation therapy or chemotherapy. - Subjects accessible for treatment and follow-up. Subjects enrolled in this trial must be treated at the participating center. - Subjects greater or equal to 18 years of age. - Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks afterwards. Exclusion Criteria: - Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study. - Women who are pregnant or breastfeeding. - Women with a positive pregnancy test on enrollment or prior to study drug administration. - Sexually active, fertile men not using adequate birth control. - Subjects with dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent. - Subjects with a serious uncontrolled medical disorder that would impair the ability of the patient to receive protocol therapy. - Subjects with a history of uncontrolled angina, arrhythmias, congestive heart failure, or myocardial infarction within the previous 6 months. - Subjects with any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. Subjects with a previous malignancy but without evidence of disease for > 5 years will be allowed to enter the trial. - Subjects with any history of severe hypersensitivity reactions and/or anaphylaxis resulting from the administration of protein based therapeutic agents. - Subjects with inadequate hematologic function defined by an absolute neutrophil count (ANC) <1,250/mm3, a platelet count <75,000/mm3, and a hemoglobin level <8 g/dL. - Subjects with inadequate hepatic function, defined by a total bilirubin level ³3 times the upper limit of normal (ULN) and an aspartate transaminase (AST) and alanine transaminase (ALT) levels >5 x ULN. - Subjects with inadequate renal function defined by a serum creatinine level >2.5 x ULN. - Prior cetuximab therapy, prior randomization on a study which includes cetuximab therapy in a treatment arm, or any other prior therapy that targets the EGFR pathway. - A history of prior therapy with a chimerized or murine monoclonal antibody. - Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study. - A history of cetuximab or therapy that targeted the EGFR receptor. - A history of prior anti-cancer murine monoclonal antibody therapy. - Additional concurrent chemotherapy or other investigational anticancer agents may not be administered to subjects on this study.
Total Enrollment:
Location and Contact Information:
Memphis Cancer Center
Memphis, Tennessee,
United States
Cancer Institute Medical Group
Los Angeles, California,
United States
NYOH
Latham, New York,
United States
New York University Medical Center
New York City, New York,
United States
Center for Oncology Research and Treatment
Dallas, Texas,
United States
Oregon Hematology Oncology Associates, P.C.
Portland, Oregon,
United States
Kentuckianna Cancer Institute
Louisville, Kentucky,
United States
Nevada Cancer Center
Las Vegas, Nevada, 89109
United States
Virginia Oncology Associates-Mid-Atlantic Consultants in Hem/Onc
Norfolk, Virginia,
United States
Comprehensive Blood and Cancer Center
Bakersfield, California,
United States
Oncology Hematology Group of South Florida
Miami, Florida,
United States
Missouri Cancer Care
St. Charles, Missouri,
United States
Green Bay Oncology
Green Bay, Wisconsin,
United States
Greater Baltimore Medical Center
Baltimore, Maryland,
United States
University Hospitals of Cleveland
Cleveland, Ohio,
United States
McCauley Cancer Center
Ypsilanti, Michigan,
United States
Benefits Healthcare Hospital
Great Falls, Montana,
United States
Cooper Health System Cancer Center
Voorhees, New Jersey,
United States
Peachtree Hematology and Oncology
Atlanta, Georgia,
United States
Florida Oncology Asociates
Jacksonville, Florida,
United States
Northwestern Connecticut Oncology/Hemaology Associates
Torrington, Connecticut,
United States
Cancer Centers of the Carolinas
Greenville, South Carolina,
United States
Park Nicollet Cancer Center
Minneapolis, Minnesota, 55416
United States
North Shore Hematology Oncology Associates
East Setauket, New York,
United States
Rocky Mountain Cancer Center
Denver, Colorado,
United States
Decatur Memorial Hospital
Decatur, Illinois,
United States
Ochsner Cancer Center
New Orleans, Louisiana,
United States
Hematology and Oncology Consultants
Orlando, Florida,
United States
Georgetown Univerisity Medical Center
Washington D.C., District of Columbia,
United States
Additional Information:
Study ID Numbers: CA225041;
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00055419
Other Colorectal Neoplasms Studies:
1. An Open Label Study of a Peptide Vaccine in Patients with Stage III Colon Cancer
2. EPO906 Therapy in Patients with Advanced Colorectal Cancer
3. A Phase II Study of 5-Fluorouracil Administered as a One Hour Infusion in Combination with Calcium Leucovorin and Interferon Alpha-2A in Advanced Colorectal Cancer
4. A Safety and Effectiveness Study of Aroplatin in Patients with Advanced Colorectal Cancer Resistant to Standard Therapies
5. Magnetic-Targeted Doxorubicin in Treating Patients with Cancer Metastatic to the Liver
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A phase II study of cetuximab in patients who have stage IV colorectal cancer
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