MedPath

Docetaxel Plus Carboplatin in Treating Patients With Advanced Cancer of the Esophagus

Phase 2
Completed
Conditions
Esophageal Cancer
Registration Number
NCT00003864
Lead Sponsor
Eastern Cooperative Oncology Group
Brief Summary

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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (74)

Emory University Hospital - Atlanta

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Atlanta, Georgia, United States

Hahnemann University Hospital

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Philadelphia, Pennsylvania, United States

University of Pennsylvania Cancer Center

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Philadelphia, Pennsylvania, United States

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

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Chicago, Illinois, United States

Veterans Affairs Medical Center - Lakeside Chicago

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Chicago, Illinois, United States

Ireland Cancer Center

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Cleveland, Ohio, United States

Beth Israel Deaconess Medical Center

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Boston, Massachusetts, United States

Fox Chase Cancer Center

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Philadelphia, Pennsylvania, United States

Veterans Affairs Medical Center - Indianapolis (Roudebush)

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Indianapolis, Indiana, United States

CCOP - Southern Nevada Cancer Research Foundation

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Las Vegas, Nevada, United States

Veterans Affairs Medical Center - Minneapolis

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Minneapolis, Minnesota, United States

Veterans Affairs Medical Center - Nashville

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Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center

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Nashville, Tennessee, United States

Veterans Affairs Medical Center - Palo Alto

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Palo Alto, California, United States

CCOP - Colorado Cancer Research Program, Inc.

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Denver, Colorado, United States

Cancer Center and Beckman Research Institute, City of Hope

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Los Angeles, California, United States

CCOP - Christiana Care Health Services

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Wilmington, Delaware, United States

University of Minnesota Cancer Center

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Minneapolis, Minnesota, United States

CCOP - Evanston

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Evanston, Illinois, United States

CCOP - Carle Cancer Center

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Urbana, Illinois, United States

Indiana University Cancer Center

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Indianapolis, Indiana, United States

CCOP - Missouri Valley Cancer Consortium

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Omaha, Nebraska, United States

Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County

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Mount Holly, New Jersey, United States

CCOP - Northern New Jersey

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Hackensack, New Jersey, United States

Riverview Medical Center

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Red Bank, New Jersey, United States

Cancer Institute of New Jersey

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New Brunswick, New Jersey, United States

Raritan Bay Medical Center

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Perth Amboy, New Jersey, United States

Veterans Affairs Medical Center - Cleveland

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Cleveland, Ohio, United States

CCOP - Geisinger Clinic and Medical Center

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Danville, Pennsylvania, United States

Veterans Affairs Medical Center - New York

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New York, New York, United States

University of Pittsburgh Cancer Institute

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Pittsburgh, Pennsylvania, United States

University of Rochester Cancer Center

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Rochester, New York, United States

CCOP - Columbus

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Columbus, Ohio, United States

CCOP - Merit Care Hospital

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Fargo, North Dakota, United States

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

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Philadelphia, Pennsylvania, United States

CCOP - Sioux Community Cancer Consortium

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Sioux Falls, South Dakota, United States

University of Wisconsin Comprehensive Cancer Center

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Madison, Wisconsin, United States

Veterans Affairs Medical Center - San Juan

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San Juan, Puerto Rico

Pretoria Academic Hospitals

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Pretoria, South Africa

CCOP - Marshfield Medical Research and Education Foundation

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Marshfield, Wisconsin, United States

Mayo Clinic Cancer Center

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Rochester, Minnesota, United States

Medical College of Wisconsin

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Milwaukee, Wisconsin, United States

Veterans Affairs Medical Center - Milwaukee (Zablocki)

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Milwaukee, Wisconsin, United States

CCOP - Sooner State

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Tulsa, Oklahoma, United States

CCOP - Illinois Oncology Research Association

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Peoria, Illinois, United States

H. Lee Moffitt Cancer Center and Research Institute

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Tampa, Florida, United States

Veterans Affairs Medical Center - Tampa (Haley)

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Tampa, Florida, United States

CCOP - Scottsdale Oncology Program

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Scottsdale, Arizona, United States

Stanford University Medical Center

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Stanford, California, United States

Walter Reed Army Medical Center

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Washington, District of Columbia, United States

Veterans Affairs Medical Center - Atlanta (Decatur)

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Decatur, Georgia, United States

CCOP - Central Illinois

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Decatur, Illinois, United States

CCOP - Iowa Oncology Research Association

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Des Moines, Iowa, United States

CCOP - Cedar Rapids Oncology Project

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Cedar Rapids, Iowa, United States

New England Medical Center Hospital

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Boston, Massachusetts, United States

Johns Hopkins Oncology Center

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Baltimore, Maryland, United States

CCOP - Kalamazoo

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Kalamazoo, Michigan, United States

CCOP - Duluth

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Duluth, Minnesota, United States

CCOP - Metro-Minnesota

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Saint Louis Park, Minnesota, United States

Veterans Affairs Medical Center - East Orange

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East Orange, New Jersey, United States

Veterans Affairs Medical Center - Albany

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Albany, New York, United States

Veterans Affairs Medical Center - Brooklyn

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Brooklyn, New York, United States

NYU School of Medicine's Kaplan Comprehensive Cancer Center

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New York, New York, United States

Albert Einstein Comprehensive Cancer Center

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Bronx, New York, United States

CCOP - Toledo Community Hospital Oncology Program

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Toledo, Ohio, United States

Veterans Affairs Medical Center - Pittsburgh

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Pittsburgh, Pennsylvania, United States

CCOP - MainLine Health

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Wynnewood, Pennsylvania, United States

Veterans Affairs Medical Center - Madison

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Madison, Wisconsin, United States

MBCCOP - San Juan

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San Juan, Puerto Rico

CCOP - Ann Arbor Regional

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Ann Arbor, Michigan, United States

Hackensack University Medical Center

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Hackensack, New Jersey, United States

Veterans Affairs Medical Center - Gainsville

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Gainesville, Florida, United States

MBCCOP - LSU Health Sciences Center

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New Orleans, Louisiana, United States

CCOP - Ochsner

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New Orleans, Louisiana, United States

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