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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


Phase 3
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Tumor Response Rate

Outcome Time Frame:

Weekly

Safety Issue:

No

Principal Investigator

Edgardo Rivera, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

ID99-242

NCT ID:

NCT00008411

Start Date:

December 1999

Completion Date:

January 2007

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms

Name

Location

MD Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
University of Texas M.D. Anderson CCOP Research BaseHouston, Texas  77030-4009