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Sponsors and Collaborators: |
US Oncology Research Bristol-Myers Squibb ImClone Systems |
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Information provided by: | US Oncology Research |
ClinicalTrials.gov Identifier: | NCT00527111 |
The purpose of this research study is to find out what effects (good and bad) cetuximab has on rectal cancer.
Condition | Intervention | Phase |
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Rectal Cancer |
Drug: Cetuximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized Phase II Trial of Pre-Operative Chemoradiotherapy With or Without Cetuximab (ERBITUX(R)) in Locally-Advanced Adenocarcinoma of the Rectum |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Note: Please see Section 8.1 for the necessary "Prestudy Assessments".
A patient will be eligible for inclusion in this study if s/he meets all of the following criteria:
White blood cell (WBC) count See protocol for specific details Absolute neutrophil count (ANC) See protocol for specific details Hemoglobin See protocol for specific details Total bilirubin See protocol for specific details AST and ALT See protocol for specific details Serum creatinine See protocol for specific details Platelet count See protocol for specific details
Prior to study enrollment, women of childbearing potential (WOCBP) must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control.
All WOCBP MUST have a negative pregnancy test within 3 weeks prior to registration (confirmed within 7 days prior to first receiving investigational product). If the pregnancy test is positive, the patient must not receive investigational product and must not be enrolled in the study.
In addition, all WOCBP should be instructed to contact the Investigator immediately if they suspect they might be pregnant (eg, missed or late menstrual period) at any time during study participation.
The Investigator must immediately notify BMS in the event of a confirmed pregnancy in a patient participating in the study.
Exclusion Criteria:
Contact: Jennifer C Davis | 214-584-3219 | Jennifer.Davis@USOncology.com |
Principal Investigator: | Andrew D McCollum, MD | US Oncology Research |
Study ID Numbers: | CA225269 |
Study First Received: | September 7, 2007 |
Last Updated: | September 7, 2007 |
ClinicalTrials.gov Identifier: | NCT00527111 History of Changes |
Health Authority: | United States: Institutional Review Board |
Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Cetuximab Rectal Neoplasm Intestinal Diseases Rectal Diseases |
Intestinal Neoplasms Digestive System Diseases Rectal Cancer Gastrointestinal Neoplasms Adenocarcinoma Colorectal Neoplasms |
Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Antineoplastic Agents Cetuximab Intestinal Diseases Rectal Diseases Pharmacologic Actions |
Intestinal Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Colorectal Neoplasms |