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Brief Title: Sutent + Taxol for Advanced Esophageal Cancer
Official Title: A Phase II Study of Sunitinib Malate (Sutent®) With Paclitaxel (Taxol®) in Patients With Advanced Esophageal Cancer
Study ID: NCT00730353
Brief Summary: Paclitaxel is known to be active as a single and combination agent in esophageal cancer, and has also been demonstrated to have anti-angiogenic properties in weekly dosing regimens. Sunitinib malate is an anti-angiogenic drug with the potential to improve responses when combined with chemotherapy, as demonstrated with other regimens in similar settings. We believe that the combination of paclitaxel and sunitinib malate offer great promise in the treatment of advanced esophageal cancer.
Detailed Description: OUTLINE: This is a multi-center study. Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle. * Paclitaxel 90 mg/m2 IV on days 1, 8 and 15. * Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion. Performance Status: ECOG (Eastern Cooperative Oncology Group) performance status 0 to 2 Life expectancy: Not specified Hematopoietic: * International Normalized Ratio (INR) \< 1.2 * Partial Thromboplastin Time (PTT) \< 1.5 x Upper Limit of Normal (ULN) * Platelets \> 100 K/mm3 * Hemoglobin \> 8 g/dL * Absolute Neutrophil Count (ANC) \> 1.0 K/mm3 Hepatic: * Aspartate transaminase (AST) ≤ 2.5 x ULN, or ≤ 5.0 x ULN if the transaminase elevation is due to known liver metastases. * Alanine transaminase (ALT) ≤ 2.5 x ULN, or ≤ 5.0 x ULN if the transaminase elevation is due to known liver metastases. * Total bilirubin \< 2.0 x ULN Renal: * Serum creatinine ≤ 2 x ULN or a calculated creatinine clearance (using Cockcroft-Gault formula) \> 50 cc/min Cardiovascular: * No history of unstable angina, myocardial infarction, coronary artery bypass grafting surgery within 12 months prior to registration for protocol therapy. Patients may be on anti-anginal medications, but must be stable on those medications for at least 6 months. * No history of New York Heart Association class II or greater congestive heart failure. Pulmonary: * Not specified
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States
Rush-Presbyterian St. Luke's Medical Center, Chicago, Illinois, United States
Medical & Surgical Specialists, LLC, Galesburg, Illinois, United States
Cancer Care Center of Southern Indiana, Bloomington, Indiana, United States
Oncology Hematology Associates of SW Indiana, Evansville, Indiana, United States
Fort Wayne Oncology & Hematology, Inc, Fort Wayne, Indiana, United States
IN Onc/Hem Associates, Indianapolis, Indiana, United States
Indiana University Simon Cancer Center, Indianapolis, Indiana, United States
Arnett Cancer Care, Lafayette, Indiana, United States
Horizon Oncology Center, Lafayette, Indiana, United States
Medical Consultants, P.C., Muncie, Indiana, United States
Monroe Medical Associates, Munster, Indiana, United States
Northern Indiana Cancer Research Consortium, South Bend, Indiana, United States
Providence Medical Group, Terre Haute, Indiana, United States
Ireland Cancer Center - University Hospitals of Cleveland, Cleveland, Ohio, United States
Name: Nasser Hanna, M.D.
Affiliation: Hoosier Cancer Research Network
Role: STUDY_CHAIR