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Docetaxel in Treating Patients With Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00008411
First received: January 6, 2001
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: Docetaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Objective Tumor Response Rate [ Time Frame: Weekly ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: December 1999
Study Completion Date: January 2007
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Docetaxel Weekly
Arm I: Docetaxel IV over 1 hour on day 1. Courses repeat every 21 days.
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 Name: 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 Name: Taxotere

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00008411

Locations
United States, Texas
MD Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
University of Texas M.D. Anderson CCOP Research Base
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Edgardo Rivera, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00008411     History of Changes
Other Study ID Numbers: ID99-242, P30CA016672, MDA-ID-99242, AVENTIS-MDA-ID-99242, NCI-1691, CDR0000068408
Study First Received: January 6, 2001
Last Updated: July 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Docetaxel
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 27, 2014