A Phase II Trial of Paclitaxel (TAXOL) Administered as a Weekly One Hour Infusion in Patients With Advanced Esophageal Cancer
OBJECTIVES: I. Determine the objective response rate of paclitaxel administered as a weekly
one hour infusion in patients with metastatic, locally recurrent, or unresectable squamous
cell carcinoma and adenocarcinoma of the esophagus. II. Evaluate the safety of paclitaxel in
this patient population. III. Assess the overall survival and quality of life of these
patients.
OUTLINE: This is an open label, multicenter study. Patients receive intravenous paclitaxel
over 1 hour weekly. Each course consists of four weeks. Patients receive treatment until
disease progression or unacceptable toxic effects is observed. Patient response is assessed
every 2 courses during the first year and then every 3 months in subsequent years. Quality
of life is assessed prior to treatment, prior to each course for 6 courses, then every 2
courses. Patients are followed every 3 months until death.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
Interventional
Primary Purpose: Treatment
David Paul Kelsen, MD
Study Chair
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
CDR0000066278
NCT00003326
September 1997
Name | Location |
---|---|
Akron City Hospital | Akron, Ohio 44304 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Albert Einstein Comprehensive Cancer Center | Bronx, New York 10461 |
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
Siouxland Hematology-Oncology | Sioux City, Iowa 51101-1733 |
NYU School of Medicine's Kaplan Comprehensive Cancer Center | New York, New York 10016 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
Loma Linda University Medical Center | Loma Linda, California 92354 |
New York Medical College | Valhalla, New York 10595 |
Harrington Cancer Center | Amarillo, Texas 79106 |
Veterans Affairs Medical Center - San Francisco | San Francisco, California 94121 |
Veterans Affairs Medical Center - Washington, DC | Washington, District of Columbia 20422 |
Michiana Hematology/Oncology P.C. | South Bend, Indiana 46617 |
Palmetto Hematology/Oncology Associates | Spartanburg, South Carolina 29303 |
Cancer Center of Southern Alabama | Mobile, Alabama 36607 |
Florida Cancer Specialists | Fort Myers, Florida 33901 |
Savannah Hematology Oncology Associates | Savannah, Georgia 31405 |
Northwest Medical Specialists, P.C. | Arlington Heights, Illinois 60004 |
Louisiana Oncology Associates | Lafayette, Louisiana 70506 |
Memorial Hospital | Worcester, Massachusetts 01605 |
Missoula Medical Oncology P.C. | Missoula, Montana 59802 |
Nevada Cancer Center | Las Vegas, Nevada 89109 |
University of Medicine and Dentistry of New Jersey - MOBILE | Newark, New Jersey 07103 |
Rochester General Hospital | Rochester, New York 14621 |
Pitt County Memorial Hospital | Greenville, North Carolina 27835-6028 |
Hollings Cancer Center | Charleston, South Carolina 29403 |
Lone Star Oncology | Austin, Texas 78759 |
Oncology Consultants | Houston, Texas 77024 |