Phase II Trial of Post-Operative Adjuvant Paclitaxel + Cisplatin in Patients With Adenocarcinoma of the Esophagus, Gastro-Esophageal Junction or Cardia
OBJECTIVES: I. Evaluate the disease free survival and overall survival of patients with
adenocarcinoma of the esophagus, gastroesophageal junction, or cardia receiving
post-operative adjuvant paclitaxel plus cisplatin.
OUTLINE: Patients undergo esophagogastrectomies within 4-12 weeks prior to the study.
Patients receive intravenous paclitaxel over 3 hours on day 1, followed by intravenous
cisplatin. Treatment is repeated every 21 days for 4 courses. Patients exhibiting disease
recurrence or unacceptable toxic effects are removed from the study. Patients are followed
every 3 months for 2 years, every 6 months for the next 3 years, and then every 12 months
thereafter.
PROJECTED ACCRUAL: A total of 55 patients will be accrued within 16 months.
Interventional
Primary Purpose: Treatment
Arlene A. Forastiere, MD
Study Chair
Sidney Kimmel Comprehensive Cancer Center
United States: Food and Drug Administration
CDR0000066109
NCT00003237
March 1998
Name | Location |
---|---|
Albert Einstein Comprehensive Cancer Center | Bronx, New York 10461 |
Kaplan Cancer Center | New York, New York 10016 |
CCOP - Ann Arbor Regional | Ann Arbor, Michigan 48106 |
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
New England Medical Center Hospital | Boston, Massachusetts 02111 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
CCOP - Northern New Jersey | Hackensack, New Jersey 07601 |
University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
CCOP - Ochsner | New Orleans, Louisiana 70121 |
CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
CCOP - Central Illinois | Springfield, Illinois 62526 |
Allegheny University Hospitals- Hahnemann | Philadelphia, Pennsylvania 19102-1192 |
CCOP - MainLine Health | Wynnewood, Pennsylvania 19096 |
Veterans Affairs Medical Center - Madison | Madison, Wisconsin 53705 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee, Wisconsin 53295 |
CCOP - Evanston | Evanston, Illinois 60201 |
Veterans Affairs Medical Center - New York | New York, New York 10010 |
Veterans Affairs Medical Center - Chicago (Lakeside) | Chicago, Illinois 60611 |
CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center | Tulsa, Oklahoma 74136 |