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Tracking Information | |||||||||
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First Received Date † | September 27, 2007 | ||||||||
Last Updated Date | April 30, 2009 | ||||||||
Start Date † | October 2007 | ||||||||
Current Primary Outcome Measures † |
Overall survival at 18 months [ Designated as safety issue: No ] | ||||||||
Original Primary Outcome Measures † | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT00536874 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title † | Gemcitabine and Oxaliplatin in Treating Patients With Pancreatic Cancer That Can Be Removed By Surgery | ||||||||
Official Title † | A Phase II Study of Neoadjuvant Gemcitabine and Oxaliplatin in Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma | ||||||||
Brief Summary | RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin works in treating patients with pancreatic cancer that can be removed by surgery. |
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Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE:
Patients undergo tumor tissue and blood sample collection periodically for correlative studies. Samples are analyzed for protein expression and tumor markers (CEA and CA19-9) pre- and post-neoadjuvant therapy via proteomic analysis. Tumor tissue samples are also banked for research purposes. After completion of study treatment, patients are followed every 3 months. |
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Study Phase | Phase II | ||||||||
Study Type † | Interventional | ||||||||
Study Design † | Treatment, Non-Randomized, 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 | ||||||||
Enrollment † | 37 | ||||||||
Completion Date | |||||||||
Estimated Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||||||
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 † | NCT00536874 | ||||||||
Responsible Party | Eileen O'Reilly, Memorial Sloan-Kettering Cancer Center | ||||||||
Secondary IDs †† | MSKCC-07113 | ||||||||
Study Sponsor † | Memorial Sloan-Kettering Cancer Center | ||||||||
Collaborators †† | National Cancer Institute (NCI) | ||||||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||||||
Verification Date | December 2008 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |