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Sponsored by: |
Massachusetts General Hospital |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00667420 |
A pilot study to determine the safety of using perioperative panitumumab with EOX in patients with adenocarcinoma of the esophagus and stomach.
Condition | Intervention | Phase |
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Esophageal Adenocarcinoma Gastric Adenocarcinoma |
Drug: panitumumab, epirubicin, oxaliplatin, xeloda |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment |
Official Title: | A Pilot Study of Perioperative Panitumumab in Combination With Epirubicin, Oxaliplatin and Xeloda in Patients With Resectable Gastroesophageal Adenocarcinoma |
Estimated Enrollment: | 30 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Pilot study
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Drug: panitumumab, epirubicin, oxaliplatin, xeloda
pilot study
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have normal organ, metabolic and marrow function as defined below:
Hematologic function, as follows:
Renal function, as follows:
Hepatic function, as follows:
Metabolic function, as follows:
Calcium < or = lower limit of normal
Exclusion Criteria:
Contact: David P Ryan, MD | 617-724-0245 | dpryan@partners.org |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Principal Investigator: David P Ryan, MD | |
DFCI | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Petet Enzinger, MD | |
Principal Investigator: Peter Enzinger, MD |
Principal Investigator: | David P Ryan, MD | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hospital ( David Ryan MD ) |
Study ID Numbers: | 07326 |
Study First Received: | April 24, 2008 |
Last Updated: | April 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00667420 History of Changes |
Health Authority: | United States: Food and Drug Administration |
gastric esophageal panitumumab |
Antimetabolites Capecitabine Digestive System Neoplasms Gastrointestinal Diseases Epirubicin Carcinoma Anti-Bacterial Agents Oxaliplatin Digestive System Diseases |
Stomach Diseases Esophageal Disorder Stomach Neoplasms Gastrointestinal Neoplasms Esophageal Diseases Stomach Cancer Adenocarcinoma Neoplasms, Glandular and Epithelial |
Antimetabolites Capecitabine Antimetabolites, Antineoplastic Neoplasms by Histologic Type Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Antibiotics, Antineoplastic Epirubicin Pharmacologic Actions Carcinoma |
Oxaliplatin Neoplasms Digestive System Diseases Neoplasms by Site Stomach Diseases Therapeutic Uses Stomach Neoplasms Gastrointestinal Neoplasms Esophageal Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |