A Phase II Study of Taxotere and Irinotecan (CPT-11) in Patients With Advanced Adenocarcinoma of the Lower Esophagus, Esophagogastric Junction, and Gastric Cardia
OBJECTIVES: I. Determine the objective tumor response rate in patients with advanced
adenocarcinoma of the lower esophagus, esophagogastric junction, and gastric cardia treated
with docetaxel and irinotecan. II. Determine time to progression and overall survival of
patients treated treated with this regimen. III. Determine the toxic effects of this regimen
in these patients. IV. Assess treatment response in these patients by determining the
prevalence of dysphagia, anorexia, and swallowing ability at diagnosis and during treatment
with this regimen.
OUTLINE: Patients receive irinotecan IV over 90 minutes followed by docetaxel IV over 1 hour
on day 1. Treatment repeats every 21 days in the absence of unacceptable toxicity or disease
progression. Patients achieving a complete response (CR) receive 2 additional courses after
CR. Patients experiencing disease progression after a CR and 2 additional courses may be
retreated with irinotecan and docetaxel. Dysphagia, anorexia, and swallowing ability are
assessed before the first course of treatment and then at each tumor assessment. Patients
are followed every 3 months for 1 year and then every 6 months for 4 years.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 12-26
months.
Interventional
Primary Purpose: Treatment
Aminah Jatoi, MD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000067479
NCT00004235
January 2000
Name | Location |
---|---|
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
CCOP - Ann Arbor Regional | Ann Arbor, Michigan 48106 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
CCOP - Duluth | Duluth, Minnesota 55805 |
CCOP - Scottsdale Oncology Program | Scottsdale, Arizona 85259-5404 |
CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
Siouxland Hematology-Oncology | Sioux City, Iowa 51101-1733 |
CCOP - Ochsner | New Orleans, Louisiana 70121 |
CentraCare Clinic | Saint Cloud, Minnesota 56303 |
CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
CCOP - Geisinger Clinic and Medical Center | Danville, Pennsylvania 17822-2001 |
Medcenter One Health System | Bismarck, North Dakota 58501 |