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

January 6, 2001
July 27, 2012
December 1999
March 2006   (final data collection date for primary outcome measure)
Objective Tumor Response Rate [ Time Frame: Weekly ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00008411 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Docetaxel in Treating Patients With Metastatic Breast Cancer
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • 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
  • 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 Weekly
    Arm I: Docetaxel IV over 1 hour on day 1. Courses repeat every 21 days.
    Intervention: Drug: Docetaxel
  • Experimental: Docetaxel Every 3 Weeks
    Arm II: Docetaxel IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days.
    Intervention: Drug: Docetaxel
Rivera E, Mejia JA, Arun BK, Adinin RB, Walters RS, Brewster A, Broglio KR, Yin G, Esmaeli B, Hortobagyi GN, Valero V. Phase 3 study comparing the use of docetaxel on an every-3-week versus weekly schedule in the treatment of metastatic breast cancer. Cancer. 2008 Apr 1;112(7):1455-61.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
January 2007
March 2006   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00008411
ID99-242, P30CA016672, MDA-ID-99242, AVENTIS-MDA-ID-99242, NCI-1691, CDR0000068408
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Edgardo Rivera, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP