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NCT00003326

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

Last Updated: 2008-07-24

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-09-30

Brief Summary

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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with metastatic, recurrent, or unresectable cancer of the esophagus.

Detailed Description

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OBJECTIVES: I. Determine the objective response rate of paclitaxel administered as a weekly one hour infusion in patients with metastatic, locally recurrent, or unresectable squamous cell carcinoma and adenocarcinoma of the esophagus. II. Evaluate the safety of paclitaxel in this patient population. III. Assess the overall survival and quality of life of these patients.

OUTLINE: This is an open label, multicenter study. Patients receive intravenous paclitaxel over 1 hour weekly. Each course consists of four weeks. Patients receive treatment until disease progression or unacceptable toxic effects is observed. Patient response is assessed every 2 courses during the first year and then every 3 months in subsequent years. Quality of life is assessed prior to treatment, prior to each course for 6 courses, then every 2 courses. Patients are followed every 3 months until death.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Conditions

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Esophageal Cancer

Keywords

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stage IV esophageal cancer recurrent esophageal cancer squamous cell carcinoma of the esophagus adenocarcinoma of the esophagus

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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paclitaxel

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 mg/dL AST or ALT no greater than 2 times upper limit of normal (ULN) Renal: Creatinine no greater than 2 times ULN Calcium no greater than 12 mg/dL Cardiovascular: No New York Heart Association class III/IV heart disease No myocardial infarction within 6 months of study No congestive heart failure No unstable angina No clinically significant pericardial effusion or arrhythmia Neurologic: No concurrent peripheral neuropathy greater than grade 1 Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active serious infection or medical illness No history of hypersensitivity to drugs containing Cremophor (teniposide, cyclosporine, or vitamin K) No invasive malignancies within 5 years, except: Curatively treated basal or squamous cell carcinoma of the skin Curatively treated carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy within 4 weeks of study No concurrent immunotherapy Chemotherapy: No more than 1 prior chemotherapy regimen or chemotherapy/radiation therapy given in a neoadjuvant or adjuvant setting No prior chemotherapy within 4 weeks of study No concurrent chemotherapy Endocrine therapy: No prior hormonal therapy within 4 weeks of study Concurrent megestrol (Megace) allowed No other concurrent hormonal therapy Radiotherapy: No prior radiotherapy within 4 weeks of study No prior radiation to greater than 30% of bone marrow No more than 1 prior chemotherapy/radiation therapy regimen given in a neoadjuvant or adjuvant setting No concurrent radiotherapy Surgery: No prior surgery within 2 weeks of study Other: No prior parenteral antibiotics within 1 week of study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Principal Investigators

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David Paul Kelsen, MD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

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Cancer Center of Southern Alabama

Mobile, Alabama, United States

Site Status

Loma Linda University Medical Center

Loma Linda, California, United States

Site Status

Veterans Affairs Medical Center - San Francisco

San Francisco, California, United States

Site Status

Veterans Affairs Medical Center - Washington, DC

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

Site Status

Florida Cancer Specialists

Fort Myers, Florida, United States

Site Status

Savannah Hematology Oncology Associates

Savannah, Georgia, United States

Site Status

Northwest Medical Specialists, P.C.

Arlington Heights, Illinois, United States

Site Status

Michiana Hematology/Oncology P.C.

South Bend, Indiana, United States

Site Status

Siouxland Hematology-Oncology

Sioux City, Iowa, United States

Site Status

Louisiana Oncology Associates

Lafayette, Louisiana, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Memorial Hospital

Worcester, Massachusetts, United States

Site Status

Missoula Medical Oncology P.C.

Missoula, Montana, United States

Site Status

Nevada Cancer Center

Las Vegas, Nevada, United States

Site Status

University of Medicine and Dentistry of New Jersey - MOBILE

Newark, New Jersey, United States

Site Status

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, United States

Site Status

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

Rochester General Hospital

Rochester, New York, United States

Site Status

Albert Einstein Comprehensive Cancer Center

The Bronx, New York, United States

Site Status

New York Medical College

Valhalla, New York, United States

Site Status

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

Site Status

Pitt County Memorial Hospital

Greenville, North Carolina, United States

Site Status

Akron City Hospital

Akron, Ohio, United States

Site Status

Hollings Cancer Center

Charleston, South Carolina, United States

Site Status

Palmetto Hematology/Oncology Associates

Spartanburg, South Carolina, United States

Site Status

Harrington Cancer Center

Amarillo, Texas, United States

Site Status

Lone Star Oncology

Austin, Texas, United States

Site Status

Oncology Consultants

Houston, Texas, United States

Site Status

University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States