Docetaxel in Treating Patients With Metastatic Breast Cancer

July 27, 2012 updated by: M.D. Anderson Cancer Center

Phase III Study Comparing the Use of Docetaxel on a Every Three-Week vs. Weekly Schedule in the Treatment of Patients With Metastatic Breast Cancer

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

PURPOSE: Randomized phase III trial to determine the effectiveness of docetaxel in treating patients who have metastatic breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare the objective tumor response rate, duration of response, time to progression, progression-free survival, and overall survival in women with metastatic breast cancer treated with docetaxel administered weekly vs every three weeks.
  • Compare the safety and toxicity of these regimens in these patients.
  • Evaluate the maintenance of relative dose intensity with each regimen in these patients.
  • Correlate pretreatment serum HER2/neu level and response with docetaxel therapy in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior taxane use (yes vs no), number of prior chemotherapy regimens for metastatic disease (0 vs 1), and participating center. Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days.
  • Arm II: Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days.

Treatment continues in both arms in the absence of disease progression or unacceptable toxicity.

Patients are followed at 3 weeks, at 3, 6, 9, and 12 months, and then annually for 4 years.

PROJECTED ACCRUAL: A total of 160 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Actual)

90

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
    • Texas
      • Houston, Texas, United States, 77030-4009
        • MD Anderson Cancer Center at University of Texas
      • Houston, Texas, United States, 77030-4009
        • University of Texas M.D. Anderson CCOP Research Base

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 confirmed metastatic breast cancer
  • Bidimensionally measurable disease
  • No uncontrolled brain metastases or leptomeningeal disease

  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Sex:

  • Female

Menopausal status:

  • Not specified

Performance status:

  • Zubrod 0-2

Life expectancy:

  • At least 3 months

Hematopoietic:

  • Platelet count at least 100,000/mm^3
  • Neutrophil count at least 1,000/mm^3
  • Hemoglobin at least 8 g/dL

Hepatic:

  • Bilirubin no greater than upper limit of normal (ULN)
  • SGOT/SGPT no greater than 1.5 times ULN (2.5 times ULN provided alkaline phosphatase no greater than ULN)
  • Alkaline phosphatase no greater than 2.5 times ULN (4 times ULN provided transaminases no greater than ULN)

Renal:

  • Creatinine no greater than 2.0 mg/dL

Neurologic:

  • No peripheral neuropathy grade 2 or greater
  • Neurologic status must be stable 2 weeks after surgery and/or radiotherapy for brain metastasis
  • No psychiatric disorders

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except non-melanoma skin cancer, carcinoma in situ of the cervix, or other curatively treated malignancy
  • No other serious condition or illness, including active infection
  • No history of hypersensitivity to polysorbate 80

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Recovered from prior chemotherapy
  • No more than 2 prior chemotherapy regimens (no more than 1 prior regimen for metastatic disease)
  • No prior paclitaxel or docetaxel (except in the adjuvant setting)
  • At least 12 months since prior adjuvant taxane (paclitaxel or docetaxel)
  • Prior anthracycline-based therapy allowed

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 2 weeks since prior radiotherapy and recovered

Surgery:

  • At least 2 weeks since prior surgery and recovered

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
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Docetaxel Weekly
Arm I: Docetaxel IV over 1 hour on day 1. Courses repeat every 21 days.
Drug: Docetaxel
Every 3 weeks at a starting dose of 75 mg/m2 IV over 1 hour on day 1, repeated every 21 days.
Other Names:
  • Taxotere
Drug: Docetaxel
35 mg/m2 IV over 30 minutes on days 1, 8, and 15, for 3 weeks followed by one week of rest repeated every 28 days.
Other Names:
  • Taxotere
Experimental: Docetaxel Every 3 Weeks
Arm II: Docetaxel IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days.
Drug: Docetaxel
Every 3 weeks at a starting dose of 75 mg/m2 IV over 1 hour on day 1, repeated every 21 days.
Other Names:
  • Taxotere
Drug: Docetaxel
35 mg/m2 IV over 30 minutes on days 1, 8, and 15, for 3 weeks followed by one week of rest repeated every 28 days.
Other Names:
  • Taxotere

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective Tumor Response Rate
Time Frame: Weekly
Weekly

Collaborators and Investigators

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

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Edgardo Rivera, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

December 1, 1999

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

January 6, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

July 30, 2012

Last Update Submitted That Met QC Criteria

July 27, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID99-242
  • P30CA016672 (U.S. NIH Grant/Contract)
  • MDA-ID-99242 (Other Identifier: UT MD Anderson Cancer Center)
  • AVENTIS-MDA-ID-99242
  • NCI-1691
  • CDR0000068408 (Registry Identifier: NCI PDQ)

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.

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