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

NCT ID: NCT00003864

Last Updated: 2023-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

1999-09-03

Brief Summary

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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

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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.

Conditions

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Esophageal Cancer

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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carboplatin

Intervention Type DRUG

docetaxel

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Eastern Cooperative Oncology Group

NETWORK

Sponsor Role lead

Principal Investigators

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Coenraad F. Slabber, MD

Role: STUDY_CHAIR

Pretoria Academic Hospital

Locations

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CCOP - Scottsdale Oncology Program

Scottsdale, Arizona, United States

Site Status

Cancer Center and Beckman Research Institute, City of Hope

Los Angeles, California, United States

Site Status

Veterans Affairs Medical Center - Palo Alto

Palo Alto, California, United States

Site Status

Stanford University Medical Center

Stanford, California, United States

Site Status

CCOP - Colorado Cancer Research Program, Inc.

Denver, Colorado, United States

Site Status

CCOP - Christiana Care Health Services

Wilmington, Delaware, United States

Site Status

Walter Reed Army Medical Center

Washington D.C., District of Columbia, United States

Site Status

Veterans Affairs Medical Center - Gainsville

Gainesville, Florida, United States

Site Status

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Site Status

Veterans Affairs Medical Center - Tampa (Haley)

Tampa, Florida, United States

Site Status

Emory University Hospital - Atlanta

Atlanta, Georgia, United States

Site Status

Veterans Affairs Medical Center - Atlanta (Decatur)

Decatur, Georgia, United States

Site Status

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, United States

Site Status

Veterans Affairs Medical Center - Lakeside Chicago

Chicago, Illinois, United States

Site Status

CCOP - Central Illinois

Decatur, Illinois, United States

Site Status

CCOP - Evanston

Evanston, Illinois, United States

Site Status

CCOP - Illinois Oncology Research Association

Peoria, Illinois, United States

Site Status

CCOP - Carle Cancer Center

Urbana, Illinois, United States

Site Status

Indiana University Cancer Center

Indianapolis, Indiana, United States

Site Status

Veterans Affairs Medical Center - Indianapolis (Roudebush)

Indianapolis, Indiana, United States

Site Status

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, United States

Site Status

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, United States

Site Status

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, United States

Site Status

CCOP - Ochsner

New Orleans, Louisiana, United States

Site Status

Johns Hopkins Oncology Center

Baltimore, Maryland, United States

Site Status

New England Medical Center Hospital

Boston, Massachusetts, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

CCOP - Ann Arbor Regional

Ann Arbor, Michigan, United States

Site Status

CCOP - Kalamazoo

Kalamazoo, Michigan, United States

Site Status

CCOP - Duluth

Duluth, Minnesota, United States

Site Status

Veterans Affairs Medical Center - Minneapolis

Minneapolis, Minnesota, United States

Site Status

University of Minnesota Cancer Center

Minneapolis, Minnesota, United States

Site Status

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Site Status

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, United States

Site Status

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, United States

Site Status

CCOP - Southern Nevada Cancer Research Foundation

Las Vegas, Nevada, United States

Site Status

Veterans Affairs Medical Center - East Orange

East Orange, New Jersey, United States

Site Status

CCOP - Northern New Jersey

Hackensack, New Jersey, United States

Site Status

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County

Mount Holly, New Jersey, United States

Site Status

Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Site Status

Raritan Bay Medical Center

Perth Amboy, New Jersey, United States

Site Status

Riverview Medical Center

Red Bank, New Jersey, United States

Site Status

Veterans Affairs Medical Center - Albany

Albany, New York, United States

Site Status

Veterans Affairs Medical Center - Brooklyn

Brooklyn, New York, United States

Site Status

Veterans Affairs Medical Center - New York

New York, New York, United States

Site Status

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, United States

Site Status

University of Rochester Cancer Center

Rochester, New York, United States

Site Status

Albert Einstein Comprehensive Cancer Center

The Bronx, New York, United States

Site Status

CCOP - Merit Care Hospital

Fargo, North Dakota, United States

Site Status

Ireland Cancer Center

Cleveland, Ohio, United States

Site Status

Veterans Affairs Medical Center - Cleveland

Cleveland, Ohio, United States

Site Status

CCOP - Columbus

Columbus, Ohio, United States

Site Status

CCOP - Toledo Community Hospital Oncology Program

Toledo, Ohio, United States

Site Status

CCOP - Sooner State

Tulsa, Oklahoma, United States

Site Status

CCOP - Geisinger Clinic and Medical Center

Danville, Pennsylvania, United States

Site Status

Hahnemann University Hospital

Philadelphia, Pennsylvania, United States

Site Status

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, United States

Site Status

Veterans Affairs Medical Center - Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

CCOP - MainLine Health

Wynnewood, Pennsylvania, United States

Site Status

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, United States

Site Status

Veterans Affairs Medical Center - Nashville

Nashville, Tennessee, United States

Site Status

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Site Status

Veterans Affairs Medical Center - Madison

Madison, Wisconsin, United States

Site Status

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, United States

Site Status

CCOP - Marshfield Medical Research and Education Foundation

Marshfield, Wisconsin, United States

Site Status

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Veterans Affairs Medical Center - Milwaukee (Zablocki)

Milwaukee, Wisconsin, United States

Site Status

MBCCOP - San Juan

San Juan, , Puerto Rico

Site Status

Veterans Affairs Medical Center - San Juan

San Juan, , Puerto Rico

Site Status

Pretoria Academic Hospitals

Pretoria, , South Africa

Site Status

Countries

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United States Puerto Rico South Africa

References

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Rossman JF, Falkson CI, Xu R, Slabber CF, Mason BA, Mulcahy MF, Benson AB 3rd. Phase II Trial of Docetaxel and Carboplatin in Patients With Advanced Squamous Carcinoma of the Esophagus (E2298): A Trial of the Eastern Cooperative Oncology Group. Gastrointest Cancer Res. 2011 Jan;4(1):9-14.

Reference Type RESULT
PMID: 21464865 (View on PubMed)

Other Identifiers

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E-2298

Identifier Type: -

Identifier Source: secondary_id

CDR0000067028

Identifier Type: -

Identifier Source: org_study_id

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