- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003864
Docetaxel Plus Carboplatin in Treating Patients With Advanced Cancer of the Esophagus
A Phase II Trial of Docetaxel and Carboplatin in Patients With Advanced Squamous Carcinoma of the Esophagus
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of docetaxel plus carboplatin in treating patients who have advanced cancer of the esophagus.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES: I. Evaluate the objective response rate in patients with advanced squamous cell carcinoma of the esophagus treated with carboplatin and docetaxel. II. Assess the toxicity of this regimen in these patients. III. Assess the time to progression and overall survival of this patient population.
OUTLINE: Patients receive docetaxel IV over 1 hour on day 1, followed by carboplatin IV over 15-30 minutes on day 1. Treatment is repeated every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until year 2, every 6 months during years 2-5, and then annually thereafter until death.
PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study at a rate of 30 patients per year.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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San Juan, Puerto Rico, 00927-5800
- MBCCOP - San Juan
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San Juan, Puerto Rico, 00927-5800
- Veterans Affairs Medical Center - San Juan
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Pretoria, South Africa, 0001
- Pretoria Academic Hospitals
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Arizona
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Scottsdale, Arizona, United States, 85259-5404
- CCOP - Scottsdale Oncology Program
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California
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Los Angeles, California, United States, 91010-3000
- Cancer Center and Beckman Research Institute, City of Hope
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Palo Alto, California, United States, 94304
- Veterans Affairs Medical Center - Palo Alto
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Stanford, California, United States, 94305-5408
- Stanford University Medical Center
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Colorado
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Denver, Colorado, United States, 80209-5031
- CCOP - Colorado Cancer Research Program, Inc.
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Delaware
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Wilmington, Delaware, United States, 19899
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, United States, 20307-5000
- Walter Reed Army Medical Center
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Florida
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Gainesville, Florida, United States, 32608-1197
- Veterans Affairs Medical Center - Gainsville
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Tampa, Florida, United States, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute
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Tampa, Florida, United States, 33612
- Veterans Affairs Medical Center - Tampa (Haley)
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University Hospital - Atlanta
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Decatur, Georgia, United States, 30033
- Veterans Affairs Medical Center - Atlanta (Decatur)
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Illinois
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Chicago, Illinois, United States, 60611-3013
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University
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Chicago, Illinois, United States, 60611
- Veterans Affairs Medical Center - Lakeside Chicago
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Decatur, Illinois, United States, 62526
- CCOP - Central Illinois
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Evanston, Illinois, United States, 60201
- CCOP - Evanston
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Peoria, Illinois, United States, 61602
- CCOP - Illinois Oncology Research Association
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Urbana, Illinois, United States, 61801
- CCOP - Carle Cancer Center
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Indiana
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Indianapolis, Indiana, United States, 46202-5289
- Indiana University Cancer Center
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Indianapolis, Indiana, United States, 46202
- Veterans Affairs Medical Center - Indianapolis (Roudebush)
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Iowa
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Cedar Rapids, Iowa, United States, 52403-1206
- CCOP - Cedar Rapids Oncology Project
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Des Moines, Iowa, United States, 50309-1016
- CCOP - Iowa Oncology Research Association
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Louisiana
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New Orleans, Louisiana, United States, 70121
- CCOP - Ochsner
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New Orleans, Louisiana, United States, 70112
- MBCCOP - LSU Health Sciences Center
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Maryland
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Baltimore, Maryland, United States, 21231-2410
- Johns Hopkins Oncology Center
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, United States, 02111
- New England Medical Center Hospital
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Michigan
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Ann Arbor, Michigan, United States, 48106
- CCOP - Ann Arbor Regional
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Kalamazoo, Michigan, United States, 49007-3731
- CCOP - Kalamazoo
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Minnesota
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Duluth, Minnesota, United States, 55805
- CCOP - Duluth
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Minneapolis, Minnesota, United States, 55417
- Veterans Affairs Medical Center - Minneapolis
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota Cancer Center
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Rochester, Minnesota, United States, 55905
- Mayo Clinic Cancer Center
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Saint Louis Park, Minnesota, United States, 55416
- CCOP - Metro-Minnesota
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Nebraska
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Omaha, Nebraska, United States, 68131
- CCOP - Missouri Valley Cancer Consortium
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Nevada
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Las Vegas, Nevada, United States, 89106
- CCOP - Southern Nevada Cancer Research Foundation
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New Jersey
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East Orange, New Jersey, United States, 07018-1095
- Veterans Affairs Medical Center - East Orange
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Hackensack, New Jersey, United States, 07601
- Hackensack University Medical Center
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Hackensack, New Jersey, United States, 07601
- CCOP - Northern New Jersey
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Mount Holly, New Jersey, United States, 08060
- Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
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New Brunswick, New Jersey, United States, 08901
- Cancer Institute of New Jersey
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Perth Amboy, New Jersey, United States, 08861
- Raritan Bay Medical Center
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Red Bank, New Jersey, United States, 07701
- Riverview Medical Center
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New York
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Albany, New York, United States, 12208
- Veterans Affairs Medical Center - Albany
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Bronx, New York, United States, 10461
- Albert Einstein Comprehensive Cancer Center
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Brooklyn, New York, United States, 11209
- Veterans Affairs Medical Center - Brooklyn
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New York, New York, United States, 10016
- NYU School of Medicine's Kaplan Comprehensive Cancer Center
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New York, New York, United States, 10010
- Veterans Affairs Medical Center - New York
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Rochester, New York, United States, 14642
- University of Rochester Cancer Center
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North Dakota
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Fargo, North Dakota, United States, 58122
- CCOP - Merit Care Hospital
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Ohio
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Cleveland, Ohio, United States, 44106-5065
- Ireland Cancer Center
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Cleveland, Ohio, United States, 44106
- Veterans Affairs Medical Center - Cleveland
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Columbus, Ohio, United States, 43206
- CCOP - Columbus
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Toledo, Ohio, United States, 43623-3456
- CCOP - Toledo Community Hospital Oncology Program
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Oklahoma
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Tulsa, Oklahoma, United States, 74136
- CCOP - Sooner State
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Pennsylvania
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Danville, Pennsylvania, United States, 17822-2001
- CCOP - Geisinger Clinic and Medical Center
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Philadelphia, Pennsylvania, United States, 19111
- Fox Chase Cancer Center
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Philadelphia, Pennsylvania, United States, 19102-1192
- Hahnemann University Hospital
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Philadelphia, Pennsylvania, United States, 19104-4283
- University of Pennsylvania Cancer Center
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Philadelphia, Pennsylvania, United States, 19107-5541
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
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Pittsburgh, Pennsylvania, United States, 15213-3489
- University of Pittsburgh Cancer Institute
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Pittsburgh, Pennsylvania, United States, 15240
- Veterans Affairs Medical Center - Pittsburgh
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Wynnewood, Pennsylvania, United States, 19096
- CCOP - MainLine Health
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South Dakota
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Sioux Falls, South Dakota, United States, 57105-1080
- CCOP - Sioux Community Cancer Consortium
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Tennessee
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Nashville, Tennessee, United States, 37232-6838
- Vanderbilt-Ingram Cancer Center
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Nashville, Tennessee, United States, 37212
- Veterans Affairs Medical Center - Nashville
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Wisconsin
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Madison, Wisconsin, United States, 53792-6164
- University of Wisconsin Comprehensive Cancer Center
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Madison, Wisconsin, United States, 53705
- Veterans Affairs Medical Center - Madison
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Marshfield, Wisconsin, United States, 54449
- CCOP - Marshfield Medical Research and Education Foundation
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Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconsin
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Milwaukee, Wisconsin, United States, 53295
- Veterans Affairs Medical Center - Milwaukee (Zablocki)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
DISEASE CHARACTERISTICS: Histologically confirmed metastatic or incurable, locally advanced squamous cell carcinoma of the esophagus Measurable disease outside of a previously radiated field required
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal SGOT no greater than 2 times upper limit of normal Renal: Creatinine normal Cardiovascular: No congestive heart failure or angina pectoris, even if medically controlled No prior myocardial infarction within the past year No clinically significant conduction system abnormalities, such as 2nd or 3rd degree heart block or bundle branch block Pulmonary: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception No active infections or medical illnesses that are uncontrolled No second malignancy other than previously treated nonmelanoma skin cancer or carcinoma in situ of the cervix or a prior malignancy from which patient has been disease free for past 3 years Caloric intake greater than 1500 calories/day Fluid intake greater than 1500 mL/day
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: Not specified
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Coenraad F. Slabber, MD, Pretoria Academic Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Esophageal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Docetaxel
- Carboplatin
Other Study ID Numbers
- CDR0000067028
- E-2298
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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