Clinical trial NCT00008411: Docetaxel in Treating Patients With Metastatic Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: stage IV breast cancer
recurrent breast cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Objective Tumor Response Rate
timeFrame: Weekly
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center at University of Texas
state: Texas
city: Houston
country: United States
facility: University of Texas M.D. Anderson CCOP Research Base
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Edgardo Rivera, MD
role: STUDY_CHAIR
References:
citation: 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. doi: 10.1002/cncr.23321.