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Sponsors and Collaborators: |
University Health Network, Toronto Pfizer |
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Information provided by: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00400114 |
The purpose of this study is to see whether or not the combination of cisplatin, irinotecan and radiation, followed by surgery, followed by oral Sutent, is effective and safe for patients with resectable esophageal cancer.
Condition | Intervention | Phase |
---|---|---|
Esophageal Cancer |
Drug: Irinotecan Drug: Cisplatin Procedure: Radiation Procedure: Surgery Drug: sunitinib (Sutent) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Adjuvant Sutent Following Chemotherapy, Radiation and Surgery For Esophageal Cancer, A Phase II Trial (ASSET) |
Estimated Enrollment: | 36 |
Study Start Date: | November 2006 |
Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
Survival outcomes for resectable esophageal cancer remain poor. Current data strongly support an adjuvant systemic strategy to improve time to progression and survival in this patient population. Adding a well-tolerated oral targeted therapy such as Sutent, after a combined chemo/radiation/surgery approach in this patient population has the potential to impact on the minimal residual disease left behind by relatively effective pre-operative chemoradiation and surgery. This has the potential to improve survival. The primary endpoint is to determine the feasibility and efficacy of adjuvant Sutent therapy (SU11248) after concurrent neoadjuvant therapy with irinotecan, cisplatin, external beam conformal radiotherapy plus surgery for potential resectable esophageal cancer. Preclinical and clinical data suggest that Sutent will have activity in esophageal cancer, as the results of Sutent activity in solid tumors appear to be superior to the results of other antiangiogenic compounds in development for esophageal cancer.
Therefore, by extrapolation from promising phase I, II and III Sutent trials we propose to translate the target effects achieved with Sutent to reduce local and systemic therapy failure, and thus metastasis in esophageal cancer.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jennifer Hornby, BSc CCRP | 416-340-4857 | Jennifer.Hornby@uhn.on.ca |
Canada, Ontario | |
University Health Network (Princess Margaret & Toronto General Hospitals) | Recruiting |
Toronto, Ontario, Canada, M5G 2C4 | |
Contact: Jennifer K Hornby, BSc CCRP 416-340-4857 Jennifer.Hornby@uhn.on.ca | |
Principal Investigator: Jennifer Knox, MD | |
The Ottawa Hospital Regional Cancer Centre | Recruiting |
Ottawa, Ontario, Canada, K1H 8L6 | |
Contact: Derek Jonker, MD 613-737-7700 ext 70168 djonker@ottawahospital.on.ca | |
Principal Investigator: Derek Jonker, MD |
Principal Investigator: | Jennifer J Knox, MD M.Sc. FRCPC | University Health Network, Toronto |
Responsible Party: | University Health Network ( Dr. Jennifer Knox ) |
Study ID Numbers: | 06-0407-C |
Study First Received: | November 15, 2006 |
Last Updated: | May 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00400114 History of Changes |
Health Authority: | Canada: Health Canada |
esophageal esophagus cancer sutent sunitinib |
Digestive System Neoplasms Gastrointestinal Diseases Esophageal Neoplasms Irinotecan Adjuvants, Immunologic Esophageal Cancer Angiogenesis Inhibitors Digestive System Diseases |
Radiation-Sensitizing Agents Cisplatin Esophageal Disorder Sunitinib Head and Neck Neoplasms Gastrointestinal Neoplasms Esophageal Diseases Antineoplastic Agents, Phytogenic |
Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Growth Substances Esophageal Neoplasms Physiological Effects of Drugs Irinotecan Enzyme Inhibitors Angiogenesis Inhibitors Pharmacologic Actions Neoplasms |
Digestive System Diseases Neoplasms by Site Radiation-Sensitizing Agents Cisplatin Sunitinib Therapeutic Uses Head and Neck Neoplasms Gastrointestinal Neoplasms Growth Inhibitors Angiogenesis Modulating Agents Esophageal Diseases Antineoplastic Agents, Phytogenic |