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Tracking Information | |||||
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First Received Date † | June 4, 2007 | ||||
Last Updated Date | April 6, 2009 | ||||
Start Date † | May 2006 | ||||
Current Primary Outcome Measures † |
Mucin 5AC protein expression measured by IHC [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00482625 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Erlotinib in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery | ||||
Official Title † | Phase IIA Trial Testing Erlotinib as an Intervention Against Intraductal Pancreatic Mucinous Neoplasms | ||||
Brief Summary | RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving erlotinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Studying the proteins expressed in samples of tumor tissue in the laboratory from patients with pancreatic cancer may help doctors identify and learn more about biomarkers related to cancer. PURPOSE: This phase II trial is looking at the effect of erlotinib on protein expression in patients with pancreatic cancer that can be removed by surgery. |
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Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: Patients receive oral erlotinib hydrochloride daily for 5-42 days. Patients then proceed to surgery. Biopsies and blood samples are taken at baseline and after completion of erlotinib hydrochloride. Samples are assessed by IHC for mucin 5AC protein expression, total and phosphorylated EGFR, total and phosphorylated AKT, phosphorylated MAPK, claudin-4, vimentin, E-cadherin, and HER-3. Pharmacological studies are also conducted. After surgery, patients are followed at 4-8 weeks. |
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Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Open Label | ||||
Condition † | Pancreatic Cancer | ||||
Intervention † |
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Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Estimated Enrollment † | 30 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00482625 | ||||
Responsible Party | Frank L. Meyskens, Jr, Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | ||||
Secondary IDs †† | UCIRVINE-UCI05-5-01 | ||||
Study Sponsor † | Chao Family Comprehensive Cancer Center | ||||
Collaborators †† | National Cancer Institute (NCI) | ||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | November 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |