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Sponsors and Collaborators: |
New York University School of Medicine Sanofi-Aventis |
---|---|
Information provided by: | New York University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00463840 |
The intention of this trial is to determine the maximum tolerated of the treatment combination and to evaluate its safety and efficacy.
Condition | Intervention | Phase |
---|---|---|
Pancreatic Cancer |
Drug: Oxaliplatin, Fluorouracil, Radiation |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II Study of Chemoradiation With Oxaliplatin and 5FU for Locally Advanced Pancreatic Cancer |
Estimated Enrollment: | 24 |
Study Start Date: | June 2004 |
Previous studies have demonstrated that neoadjuvant chemoradiation can lead to improved survival with a portion of patients proceeding to resection. This trial will incorporate a similar trial structure using newer agents in patients who present with locally advanced unresectable pancreatic cancer. Specifically oxaliplatin will be used owing to its greater activity in comparison to cisplatin and favorable therapeutic index in combination with radiation compared to gemcitabine.
In summary, the primary objective of the phase I portion of the trial is to determine the maximum tolerated dose of this combination. Following the determination of this dose, the phase II portion of the trial will characterize the toxicity of this regimen as well as evaluate for long-term efficacy.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Inclusion:
Exclusion Criteria:
United States, New York | |
NYU Cancer Institute | Recruiting |
New York, New York, United States, 10016 | |
Contact: Hyemin Choi, RN 212-263-5403 hyemin.choi@nyumc.org | |
Principal Investigator: Theresa Ryan, MD |
Principal Investigator: | Theresa Ryan, MD | New York University School of Medicine |
Responsible Party: | New York University School of Medicine ( Theresa Ryan ) |
Study ID Numbers: | 03-64, H11640 |
Study First Received: | April 18, 2007 |
Last Updated: | May 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00463840 |
Health Authority: | United States: Institutional Review Board |
Locally advanced pancreatic cancer |
Oxaliplatin Digestive System Diseases Digestive System Neoplasms Fluorouracil Pancreatic Neoplasms |
Endocrine System Diseases Pancreatic Diseases Gastrointestinal Neoplasms Endocrinopathy Endocrine Gland Neoplasms |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site Immunologic Factors Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |