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Sponsors and Collaborators: |
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00702884 |
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with relapsed or refractory esophageal or gastroesophageal junction cancer.
Condition | Intervention | Phase |
---|---|---|
Esophageal Cancer |
Drug: sunitinib malate Genetic: TdT-mediated dUTP nick end labeling assay Other: immunoenzyme technique Other: immunohistochemistry staining method Other: laboratory biomarker analysis Procedure: computed tomography Procedure: dynamic contrast-enhanced magnetic resonance imaging Procedure: positron emission tomography |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Mechanistic Radiographic and Biologic Phase 2 Single Agent Study of Sunitinib Malate in Relapsed/Refractory Esophageal and Gastroesophageal Cancers |
Estimated Enrollment: | 25 |
Study Start Date: | June 2008 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo blood and tumor tissue sample collection periodically for correlative laboratory studies. Tumor tissue samples are assessed by immunohistochemistry and TUNEL for detection and quantitation of mean vessel density, proliferating tumor cells, and apoptosis. Tumor tissue samples are also assessed by immunohistochemistry for MAPK levels. Blood samples are analyzed by ELISA for VEGF, PlGF, sVEGFR2, and sVEGFR3 levels. Patients also undergo PET/CT scan and dynamic contrast-enhanced MRI periodically for correlative studies.
After completion of study treatment, patients are followed for at least 6 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed esophageal or gastroesophageal junction carcinoma that is not amenable to curative surgery or other curative therapy
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No concurrent therapeutic doses of coumarin-derivative anticoagulants, such as warfarin
United States, Ohio | |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Recruiting |
Columbus, Ohio, United States, 43210-1240 | |
Contact: Tanios Bekaii-Saab, MD 866-627-7616 |
Principal Investigator: | Tanios Bekaii-Saab, MD | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
Responsible Party: | Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center ( Tanios Bekaii-Saab ) |
Study ID Numbers: | CDR0000597858, OSU-07121, OSU-2008C0028 |
Study First Received: | June 19, 2008 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00702884 History of Changes |
Health Authority: | Unspecified |
recurrent esophageal cancer stage III esophageal cancer stage IV esophageal cancer |
Digestive System Neoplasms Digestive System Diseases Sunitinib Esophageal Disorder Gastrointestinal Diseases Head and Neck Neoplasms |
Esophageal Neoplasms Gastrointestinal Neoplasms Esophageal Cancer Esophageal Diseases Angiogenesis Inhibitors Recurrence |
Digestive System Neoplasms Gastrointestinal Diseases Antineoplastic Agents Growth Substances Esophageal Neoplasms Physiological Effects of Drugs Angiogenesis Inhibitors Pharmacologic Actions Neoplasms |
Digestive System Diseases Neoplasms by Site Sunitinib Head and Neck Neoplasms Therapeutic Uses Gastrointestinal Neoplasms Growth Inhibitors Angiogenesis Modulating Agents Esophageal Diseases |