Esophageal Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Esophageal Cancer

Phase:

Phase 2

Study ID:

NCT00003864

Recruitment Status:

Completed

Sponsor:

Eastern Cooperative Oncology Group

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There are 68 Locations for this study

See Locations Near You

CCOP - Scottsdale Oncology Program
Scottsdale Arizona, 85259, United States
Cancer Center and Beckman Research Institute, City of Hope
Los Angeles California, 91010, United States
Veterans Affairs Medical Center - Palo Alto
Palo Alto California, 94304, United States
Stanford University Medical Center
Stanford California, 94305, United States
CCOP - Colorado Cancer Research Program, Inc.
Denver Colorado, 80209, United States
CCOP - Christiana Care Health Services
Wilmington Delaware, 19899, United States
Walter Reed Army Medical Center
Washington District of Columbia, 20307, United States
Veterans Affairs Medical Center - Gainsville
Gainesville Florida, 32608, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa Florida, 33612, United States
Veterans Affairs Medical Center - Tampa (Haley)
Tampa Florida, 33612, United States
Emory University Hospital - Atlanta
Atlanta Georgia, 30322, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur Georgia, 30033, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago Illinois, 60611, United States
Veterans Affairs Medical Center - Lakeside Chicago
Chicago Illinois, 60611, United States
CCOP - Central Illinois
Decatur Illinois, 62526, United States
CCOP - Evanston
Evanston Illinois, 60201, United States
CCOP - Illinois Oncology Research Association
Peoria Illinois, 61602, United States
CCOP - Carle Cancer Center
Urbana Illinois, 61801, United States
Indiana University Cancer Center
Indianapolis Indiana, 46202, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis Indiana, 46202, United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids Iowa, 52403, United States
CCOP - Iowa Oncology Research Association
Des Moines Iowa, 50309, United States
MBCCOP - LSU Health Sciences Center
New Orleans Louisiana, 70112, United States
CCOP - Ochsner
New Orleans Louisiana, 70121, United States
Johns Hopkins Oncology Center
Baltimore Maryland, 21231, United States
New England Medical Center Hospital
Boston Massachusetts, 02111, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
CCOP - Ann Arbor Regional
Ann Arbor Michigan, 48106, United States
CCOP - Kalamazoo
Kalamazoo Michigan, 49007, United States
CCOP - Duluth
Duluth Minnesota, 55805, United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis Minnesota, 55417, United States
University of Minnesota Cancer Center
Minneapolis Minnesota, 55455, United States
Mayo Clinic Cancer Center
Rochester Minnesota, 55905, United States
CCOP - Metro-Minnesota
Saint Louis Park Minnesota, 55416, United States
CCOP - Missouri Valley Cancer Consortium
Omaha Nebraska, 68131, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas Nevada, 89106, United States
Veterans Affairs Medical Center - East Orange
East Orange New Jersey, 07018, United States
CCOP - Northern New Jersey
Hackensack New Jersey, 07601, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
Mount Holly New Jersey, 08060, United States
Cancer Institute of New Jersey
New Brunswick New Jersey, 08901, United States
Raritan Bay Medical Center
Perth Amboy New Jersey, 08861, United States
Riverview Medical Center
Red Bank New Jersey, 07701, United States
Veterans Affairs Medical Center - Albany
Albany New York, 12208, United States
Albert Einstein Comprehensive Cancer Center
Bronx New York, 10461, United States
Veterans Affairs Medical Center - Brooklyn
Brooklyn New York, 11209, United States
Veterans Affairs Medical Center - New York
New York New York, 10010, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York New York, 10016, United States
University of Rochester Cancer Center
Rochester New York, 14642, United States
CCOP - Merit Care Hospital
Fargo North Dakota, 58122, United States
Ireland Cancer Center
Cleveland Ohio, 44106, United States
Veterans Affairs Medical Center - Cleveland
Cleveland Ohio, 44106, United States
CCOP - Columbus
Columbus Ohio, 43206, United States
CCOP - Toledo Community Hospital Oncology Program
Toledo Ohio, 43623, United States
CCOP - Sooner State
Tulsa Oklahoma, 74136, United States
CCOP - Geisinger Clinic and Medical Center
Danville Pennsylvania, 17822, United States
Hahnemann University Hospital
Philadelphia Pennsylvania, 19102, United States
University of Pennsylvania Cancer Center
Philadelphia Pennsylvania, 19104, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
University of Pittsburgh Cancer Institute
Pittsburgh Pennsylvania, 15213, United States
Veterans Affairs Medical Center - Pittsburgh
Pittsburgh Pennsylvania, 15240, United States
CCOP - MainLine Health
Wynnewood Pennsylvania, 19096, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls South Dakota, 57105, United States
Veterans Affairs Medical Center - Nashville
Nashville Tennessee, 37212, United States
Vanderbilt-Ingram Cancer Center
Nashville Tennessee, 37232, United States
Veterans Affairs Medical Center - Madison
Madison Wisconsin, 53705, United States
University of Wisconsin Comprehensive Cancer Center
Madison Wisconsin, 53792, United States
CCOP - Marshfield Medical Research and Education Foundation
Marshfield Wisconsin, 54449, United States
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee Wisconsin, 53295, United States
MBCCOP - San Juan
San Juan , 00927, Puerto Rico
Veterans Affairs Medical Center - San Juan
San Juan , 00927, Puerto Rico
Pretoria Academic Hospitals
Pretoria , 0001, South Africa

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Study ID:

NCT00003864

Recruitment Status:

Completed

Sponsor:


Eastern Cooperative Oncology Group

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