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Home > "D" Clinical Trials Conditions > Docetaxel Plus Carboplatin in Treating Patients With Advanced Cancer of the Esophagus

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



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

For Condition: stage 4 esophageal cancer,squamous cell carcinoma of the esophagus,stage 3 esophageal cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Eastern Cooperative Oncology Group
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
CoenraadSlabber,  Study Chair,  Eastern Cooperative Oncology Group

Veterans Affairs Medical Center - Nashville
Nashville,  Tennessee,  37212
United States
 

CCOP - Geisinger Clinic and Medical Center
Danville,  Pennsylvania,  17822-2001
United States
 

CCOP - Scottsdale Oncology Program
Scottsdale,  Arizona,  85259-5404
United States
 

Mayo Clinic Cancer Center
Rochester,  Minnesota,  55905
United States
 

Albert Einstein Comprehensive Cancer Center
Bronx,  New York,  10461
United States
 

Veterans Affairs Medical Center - Lakeside Chicago
Chicago,  Illinois,  60611
United States
 

Veterans Affairs Medical Center - Cleveland
Cleveland,  Ohio,  44106
United States
 

Veterans Affairs Medical Center - Minneapolis
Minneapolis,  Minnesota,  55417
United States
 

Veterans Affairs Medical Center - East Orange
East Orange,  New Jersey,  07018-1095
United States
 

Veterans Affairs Medical Center - Pittsburgh
Pittsburgh,  Pennsylvania,  15240
United States
 

MBCCOP - San Juan
San Juan,  ,  00927-5800
Puerto Rico
 

Veterans Affairs Medical Center - New York
New York City,  New York,  10010
United States
 

Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago,  Illinois,  60611-3013
United States
 

H. Lee Moffitt Cancer Center and Research Institute
Tampa,  Florida,  33612-9497
United States
 

Veterans Affairs Medical Center - Albany
Albany,  New York,  12208
United States
 

University of Rochester Cancer Center
Rochester,  New York,  14642
United States
 

Veterans Affairs Medical Center - Gainsville
Gainesville,  Florida,  32608-1197
United States
 

University of Pittsburgh Cancer Institute
Pittsburgh,  Pennsylvania,  15213-3489
United States
 

Veterans Affairs Medical Center - San Juan
San Juan,  ,  00927-5800
Puerto Rico
 

Cancer Center and Beckman Research Institute, City of Hope
Los Angeles,  California,  91010-3000
United States
 

Hackensack University Medical Center
Hackensack,  New Jersey,  07601
United States
 

Indiana University Cancer Center
Indianapolis,  Indiana,  46202-5289
United States
 

Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur,  Georgia,  30033
United States
 

Medical College of Wisconsin
Milwaukee,  Wisconsin,  53226
United States
 

Vanderbilt-Ingram Cancer Center
Nashville,  Tennessee,  37232-6838
United States
 

Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis,  Indiana,  46202
United States
 

CCOP - Iowa Oncology Research Association
Des Moines,  Iowa,  50309-1016
United States
 

NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City,  New York,  10016
United States
 

CCOP - Illinois Oncology Research Association
Peoria,  Illinois,  61602
United States
 

University of Wisconsin Comprehensive Cancer Center
Madison,  Wisconsin,  53792-6164
United States
 

CCOP - Marshfield Medical Research and Education Foundation
Marshfield,  Wisconsin,  54449
United States
 

CCOP - Sioux Community Cancer Consortium
Sioux Falls,  South Dakota,  57105-1080
United States
 

Walter Reed Army Medical Center
Washington D.C.,  District of Columbia,  20307-5000
United States
 

Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
Mount Holly,  New Jersey,  08060
United States
 

CCOP - Kalamazoo
Kalamazoo,  Michigan,  49007-3731
United States
 

Raritan Bay Medical Center
Perth Amboy,  New Jersey,  08861
United States
 

CCOP - Colorado Cancer Research Program, Inc.
Denver,  Colorado,  80209-5031
United States
 

CCOP - Sooner State
Tulsa,  Oklahoma,  74136
United States
 

Hahnemann University Hospital
Philadelphia,  Pennsylvania,  19102-1192
United States
 

Veterans Affairs Medical Center - Palo Alto
Palo Alto,  California,  94304
United States
 

Veterans Affairs Medical Center - Brooklyn
Brooklyn,  New York,  11209
United States
 

CCOP - Ann Arbor Regional
Ann Arbor,  Michigan,  48106
United States
 

Ireland Cancer Center
Cleveland,  Ohio,  44106-5065
United States
 

CCOP - Metro-Minnesota
St. Louis Park,  Minnesota,  55416
United States
 

Riverview Medical Center
Red Bank,  New Jersey,  07701
United States
 

Veterans Affairs Medical Center - Tampa (Haley)
Tampa,  Florida,  33612
United States
 

Pretoria Academic Hospitals
Pretoria,  ,  0001
South Africa
 

CCOP - Christiana Care Health Services
Wilmington,  Delaware,  19899
United States
 

MBCCOP - LSU Health Sciences Center
New Orleans,  Louisiana,  70112
United States
 

CCOP - Northern New Jersey
Hackensack,  New Jersey,  07601
United States
 

Emory University Hospital - Atlanta
Atlanta,  Georgia,  30322
United States
 

University of Minnesota Cancer Center
Minneapolis,  Minnesota,  55455
United States
 

Veterans Affairs Medical Center - Madison
Madison,  Wisconsin,  53705
United States
 

Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee,  Wisconsin,  53295
United States
 

CCOP - Cedar Rapids Oncology Project
Cedar Rapids,  Iowa,  52403-1206
United States
 

CCOP - Missouri Valley Cancer Consortium
Omaha,  Nebraska,  68131
United States
 

Stanford University Medical Center
Stanford,  California,  94305-5408
United States
 

Cancer Institute of New Jersey
New Brunswick,  New Jersey,  08901
United States
 

Johns Hopkins Oncology Center
Baltimore,  Maryland,  21231-2410
United States
 

New England Medical Center Hospital
Boston,  Massachusetts,  02111
United States
 

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia,  Pennsylvania,  19107-5541
United States
 

CCOP - Duluth
Duluth,  Minnesota,  55805
United States
 

University of Pennsylvania Cancer Center
Philadelphia,  Pennsylvania,  19104-4283
United States
 

CCOP - Merit Care Hospital
Fargo,  North Dakota,  58122
United States
 

CCOP - Carle Cancer Center
Urbana,  Illinois,  61801
United States
 

CCOP - MainLine Health
Wynnewood,  Pennsylvania,  19096
United States
 

CCOP - Toledo Community Hospital Oncology Program
Toledo,  Ohio,  43623-3456
United States
 

CCOP - Columbus
Columbus,  Ohio,  43206
United States
 

CCOP - Evanston
Evanston,  Illinois,  60201
United States
 

CCOP - Southern Nevada Cancer Research Foundation
Las Vegas,  Nevada,  89106
United States
 

CCOP - Central Illinois
Decatur,  Illinois,  62526
United States
 

Fox Chase Cancer Center
Philadelphia,  Pennsylvania,  19111
United States
 

CCOP - Ochsner
New Orleans,  Louisiana,  70121
United States
 

Beth Israel Deaconess Medical Center
Boston,  Massachusetts,  02215
United States
 


Additional Information:
Study ID Numbers:
  CDR0000067028;  E-2298
Study Start Date: July 1999
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003864

Other Squamous Cell Carcinoma Of The Esophagus Studies:
1. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Esophageal Cancer

2. PNU-93914 in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus

3. Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus

4. Oxaliplatin and Fluorouracil Plus Radiation Therapy in Treating Patients With Primary Esophageal or Stomach Cancer

5. Paclitaxel in Treating Patients With Metastatic, Recurrent, or Unresectable Cancer of the Esophagus

Related Studies:

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

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