Paclitaxel or Docetaxel in Treating Women With Advanced Breast Cancer

August 1, 2013 updated by: Aventis Pharmaceuticals

PHASE III COMPARISON OF TAXOTERE (DOCETAXEL) AND TAXOL (PACLITAXEL) IN PATIENTS WITH ADVANCED BREAST CANCER

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether paclitaxel is more effective than docetaxel for breast cancer.

PURPOSE: Randomized phase III trial to study the effectiveness of paclitaxel or docetaxel in treating women with stage IIIB or metastatic breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare the response rate in women with metastatic or locally advanced, inoperable adenocarcinoma of the breast treated with docetaxel vs paclitaxel.
  • Compare the toxicity of these regimens in these patients.
  • Compare the time to disease progression, duration of response, quality of life, and survival of patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive paclitaxel IV over 3 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and after courses 4 and 6.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 400 patients (200 per arm) will be accrued for this study.

Study Type

Interventional

Phase

  • Phase 3

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
      • Birmingham, Alabama, United States, 35213
        • Montclair Regional Cancer Center
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Highlands Oncology Group, P.A. - Fayetteville
      • Jonesboro, Arkansas, United States, 72401-3125
        • Northeast Arkansas Clinic
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Greenbrae, California, United States, 94904-2007
        • California Cancer Care, Inc.
      • La Jolla, California, United States, 92037
        • Green Cancer Center at Scripps Clinic
      • San Diego, California, United States, 92121
        • Sidney Kimmel Cancer Center
    • Colorado
      • Denver, Colorado, United States, 80010
        • University of Colorado Cancer Center at University of Colorado Health Sciences Center
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • Norwich Cancer Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington University Medical Center
    • Florida
      • Jacksonville, Florida, United States, 32207-8554
        • Baptist Regional Cancer Institute - Jacksonville
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Georgia Cancer Specialists - DeKalb
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush-Presbyterian-St. Luke's Medical Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • James Graham Brown Cancer Center at University of Louisville
    • Maine
      • Scarborough, Maine, United States, 04074
        • Maine Center for Cancer Medicine and Blood Disorders - Scarborough
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • TUFTS - New England Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0942
        • University of Michigan Comprehensive Cancer Center
      • Southfield, Michigan, United States, 48076-3779
        • Southfield Oncology Institute, Inc.
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Mercy Arch Hematology Oncology, P.C.
    • North Carolina
      • Charlotte, North Carolina, United States, 28232-2861
        • Blumenthal Cancer Center at Carolinas Medical Center
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Hematology-Oncology Associates
    • Ohio
      • Cincinnati, Ohio, United States, 45267-0501
        • Charles M. Barrett Cancer Center at University Hospital
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Columbus, Ohio, United States, 43235
        • Hematology Oncology Consultants Inc
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033-0850
        • Penn State Cancer Institute at Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19107
        • Oncology-Hematology Associates
    • Rhode Island
      • Providence, Rhode Island, United States, 02908-4735
        • Roger Williams Medical Center
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Greenville Hospital System
    • Tennessee
      • Knoxville, Tennessee, United States, 37901
        • Baptist Regional Cancer Center - Knoxville
    • Texas
      • Dallas, Texas, United States, 75246
        • Charles A. Sammons Cancer Center
      • San Antonio, Texas, United States, 78284-7811
        • University of Texas Health Science Center at San Antonio
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226-3596
        • Medical College of Wisconsin Cancer Center

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

Female

Description

DISEASE CHARACTERISTICS:

  • Histologically proven metastatic or locally advanced, inoperable adenocarcinoma of the breast

    • Clinically evident metastases (e.g., clearly malignant lesions on chest x-ray or CT or abdominal CT do not require histologic confirmation)
    • Hot spots on bone scan not shown to be malignant on plain x-rays are not adequate evidence of malignant disease in the absence of other lesions

  • Must meet 1 of the following conditions:

    • Disease progression after 1 prior chemotherapy regimen for locally advanced or metastatic disease (which may or may not have followed a separate adjuvant regimen using chemotherapy or hormonal therapy)
    • Locally advanced or metastatic disease during or after 1 adjuvant or neoadjuvant chemotherapy regimen
    • One of the above chemotherapy regimens must have contained an anthracycline (e.g., doxorubicin, but not mitoxantrone)
    • Single drug substitution (e.g., methotrexate for doxorubicin) during prior combination chemotherapy allowed
  • Bidimensionally measurable
  • No clinical or radiographic evidence of brain or leptomeningeal disease

  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Sex:

  • Female

Menopausal status:

  • Not specified

Performance status:

  • Karnofsky 60-100% OR
  • ECOG 0-2

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • Absolute neutrophil count at least 2,000/mm3
  • Platelet count at least 100,000/mm3

Hepatic:

  • Bilirubin normal
  • SGOT no greater than 2.5 times upper limit of normal

Renal:

  • Creatinine no greater than 2.0 mg/dL
  • No uncontrolled hypercalcemia

Cardiovascular:

  • No myocardial infarction within the past 6 months
  • No history of arrhythmia requiring treatment
  • No heart block
  • No clinical evidence of congestive heart failure
  • No unstable angina (e.g., new onset, crescendo, or rest angina)
  • Stable exertional angina allowed

Other:

  • No current symptomatic grade 2 or greater peripheral neuropathy
  • No history of hypersensitivity to products containing Cremophor EL (e.g., cyclosporine or teniposide) or Polysorbate 80 (e.g., IV etoposide)
  • No serious infection
  • No significant psychiatric disease that would preclude study
  • No other malignancy within the past 5 years except nonmelanomatous skin cancer or completely excised carcinoma in situ of the cervix
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior bone marrow or stem cell transplantation

Chemotherapy:

  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy (2 weeks for oral cyclophosphamide or 6 weeks for nitrosoureas or mitomycin)
  • No prior high-dose chemotherapy given with ablative intent
  • No prior taxoids
  • No other concurrent antineoplastic therapy

Endocrine therapy:

  • See Disease Characteristics
  • Prior hormonal therapy as adjuvant therapy or for metastatic disease allowed
  • At least 1 week since prior hormonal therapy

  • No concurrent corticosteroids except:

    • Prophylaxis or treatment for acute hypersensitivity reactions
    • Chronic therapy (more than 6 months) at low doses (20 mg/day or less of methylprednisolone or equivalent)

Radiotherapy:

  • At least 4 weeks since prior radiotherapy to major bone marrow areas
  • No prior high-dose radiotherapy given with ablative intent
  • No concurrent radiotherapy except limited palliative radiotherapy (e.g., for a solitary rib fracture) during objective response

Surgery:

  • See Disease Characteristics
  • More than 2 weeks since prior surgery except simple biopsy or placement of venous access device

Other:

  • At least 4 weeks since prior investigational drugs
  • Concurrent medications known to alter cardiac conduction (e.g., digoxin, beta blockers, or calcium channel blockers) allowed
  • No concurrent ketoconazole
  • No concurrent bisphosphonates unless initiated more than 3 months before randomization
  • No concurrent experimental drug or therapy

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
  • Allocation: Randomized
  • Masking: None (Open Label)

Collaborators and Investigators

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

Sponsor

Aventis Pharmaceuticals

Investigators

  • Study Chair: Peter M. Ravdin, MD, The University of Texas Health Science Center at San Antonio

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

August 1, 1994

Study Completion (Actual)

June 1, 2004

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

August 2, 2013

Last Update Submitted That Met QC Criteria

August 1, 2013

Last Verified

April 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVENTIS-56976-TAX-311
  • CDR0000064232 (Registry Identifier: PDQ (Physician Data Query))
  • RP-56976-TAX-311
  • NCI-V95-0680

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 Breast Cancer

Clinical Trials on docetaxel

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe