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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00536874 |
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.
Condition | Intervention | Phase |
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Pancreatic Cancer |
Drug: gemcitabine hydrochloride Drug: oxaliplatin Procedure: adjuvant therapy Procedure: conventional surgery Procedure: laboratory biomarker analysis Procedure: neoadjuvant therapy Procedure: protein expression analysis Procedure: proteomic profiling |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | A Phase II Study of Neoadjuvant Gemcitabine and Oxaliplatin in Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma |
Estimated Enrollment: | 37 |
Study Start Date: | October 2007 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed pancreatic adenocarcinoma
No histology other than adenocarcinoma (e.g., neuroendocrine cancer or acinar cancer)
Radiographically resectable pancreatic cancer, as determined by a surgical oncologist
No evidence of distant metastases by CT scan
PATIENT CHARACTERISTICS:
No active infection, except for resolving cholangitis, that would preclude study enrollment
PRIOR CONCURRENT THERAPY:
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10021-0009 | |
Contact: Eileen O'Reilly, MD 212-639-6672 oreillye@mskcc.org |
Principal Investigator: | Eileen O'Reilly, MD | Memorial Sloan-Kettering Cancer Center |
Principal Investigator: | Peter J. Allen, MD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Eileen O'Reilly ) |
Study ID Numbers: | CDR0000566023, MSKCC-07113 |
Study First Received: | September 27, 2007 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00536874 |
Health Authority: | Unspecified |
adenocarcinoma of the pancreas stage I pancreatic cancer stage II pancreatic cancer stage III pancreatic cancer |
Oxaliplatin Digestive System Diseases Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Pancreatic Diseases |
Gastrointestinal Neoplasms Endocrinopathy Gemcitabine Adenocarcinoma Pancrelipase Endocrine Gland Neoplasms |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |