A Phase II Study of Sunitinib Malate (Sutent®) With Paclitaxel (Taxol®) in Patients With Advanced Esophageal Cancer
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 performance status 0 to 2
Life expectancy: Not specified
- INR < 1.2
- 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
- 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
- Serum creatinine ≤ 2 x ULN or a calculated creatinine clearance (using Cockcroft-Gault
formula) > 50 cc/min
- 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
- No history of New York Heart Association class II or greater congestive heart failure.
- Not specified
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the rate of non-progressive disease at 24 weeks from the first dose of the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma.
Nasser Hanna, M.D.
Hoosier Oncology Group
United States: Institutional Review Board
|Northwestern University Feinberg School of Medicine||Chicago, Illinois 60611|
|Arnett Cancer Care||Lafayette, Indiana 47904|
|Northern Indiana Cancer Research Consortium||South Bend, Indiana|
|Medical & Surgical Specialists, LLC||Galesburg, Illinois 61401|
|Cancer Care Center Of Southern Indiana||Bloomington, Indiana 47403|
|Horizon Oncology Center||Lafayette, Indiana 47905|
|Oncology Hematology Associates of SW Indiana||Evansville, Indiana 47714|
|Providence Medical Group||Terre Haute, Indiana 47802|
|Medical Consultants, P.C.||Muncie, Indiana 47303|
|Fort Wayne Oncology & Hematology, Inc||Fort Wayne, Indiana 46815|
|Indiana University Simon Cancer Center||Indianapolis, Indiana 46202|
|IN Onc/Hem Associates||Indianapolis, Indiana 46202|
|Monroe Medical Associates||Munster, Indiana 46321|
|Rush-Presbyterian St. Luke's Medical Center||Chicago, Illinois 60612|
|Ireland Cancer Center - University Hospitals of Cleveland||Cleveland, Ohio 44106|