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

July 23, 2008 updated by: Theradex

A Phase II Trial of Paclitaxel (TAXOL) Administered as a Weekly One Hour Infusion in Patients With Advanced Esophageal Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36607
        • Cancer Center of Southern Alabama
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University Medical Center
      • San Francisco, California, United States, 94121
        • Veterans Affairs Medical Center - San Francisco
    • District of Columbia
      • Washington, District of Columbia, United States, 20422
        • Veterans Affairs Medical Center - Washington, DC
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Florida Cancer Specialists
    • Georgia
      • Savannah, Georgia, United States, 31405
        • Savannah Hematology Oncology Associates
    • Illinois
      • Arlington Heights, Illinois, United States, 60004
        • Northwest Medical Specialists, P.C.
    • Indiana
      • South Bend, Indiana, United States, 46617
        • Michiana Hematology/Oncology P.C.
    • Iowa
      • Sioux City, Iowa, United States, 51101-1733
        • Siouxland Hematology-Oncology
    • Louisiana
      • Lafayette, Louisiana, United States, 70506
        • Louisiana Oncology Associates
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Worcester, Massachusetts, United States, 01605
        • Memorial Hospital
    • Montana
      • Missoula, Montana, United States, 59802
        • Missoula Medical Oncology P.C.
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Nevada Cancer Center
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • University of Medicine and Dentistry of New Jersey - MOBILE
    • New York
      • Bronx, New York, United States, 10461
        • Albert Einstein Comprehensive Cancer Center
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, United States, 10016
        • NYU School of Medicine's Kaplan Comprehensive Cancer Center
      • Rochester, New York, United States, 14621
        • Rochester General Hospital
      • Valhalla, New York, United States, 10595
        • New York Medical College
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Comprehensive Cancer Center
      • Greenville, North Carolina, United States, 27835-6028
        • Pitt County Memorial Hospital
    • Ohio
      • Akron, Ohio, United States, 44309
        • Akron City Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Hollings Cancer Center
      • Spartanburg, South Carolina, United States, 29303
        • Palmetto Hematology/Oncology Associates
    • Texas
      • Amarillo, Texas, United States, 79106
        • Harrington Cancer Center
      • Austin, Texas, United States, 78759
        • Lone Star Oncology
      • Houston, Texas, United States, 77030-4009
        • University of Texas - MD Anderson Cancer Center
      • Houston, Texas, United States, 77024
        • Oncology Consultants
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Histologically proven metastatic, locally recurrent, or unresectable squamous cell carcinoma or adenocarcinoma of the esophagus The bulk of the tumor must involve the esophagus or gastroesophageal (GE) junction (for tumors extending between the GE junction into the proximal stomach) Gastric cancers with only minor GE junction or distal esophagus involvement are not eligible Measurable or evaluable disease No prior treatment for metastatic disease No brain metastases No osseous metastases as only site of disease

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Theradex

Investigators

  • Study Chair: David Paul Kelsen, MD, Memorial Sloan Kettering Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1997

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

May 19, 2004

First Posted (Estimate)

May 20, 2004

Study Record Updates

Last Update Posted (Estimate)

July 24, 2008

Last Update Submitted That Met QC Criteria

July 23, 2008

Last Verified

April 1, 2001

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000066278
  • THERADEX-B97-4250
  • BMS-TAX/MEN.04
  • MSKCC-98018
  • NYU-9801
  • NCI-V98-1414

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Esophageal Cancer

Clinical Trials on paclitaxel

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe