NCT00008411

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at below P25 for phase_3 breast-cancer

Timeline
Completed

Started Dec 1999

Typical duration for phase_3 breast-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1999

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2001

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

July 30, 2012

Status Verified

July 1, 2012

Enrollment Period

6.3 years

First QC Date

January 6, 2001

Last Update Submit

July 27, 2012

Conditions

Breast Cancer

Keywords

stage IV breast cancerrecurrent breast cancer

Outcome Measures

Primary Outcomes (1)

  • Objective Tumor Response Rate

    Weekly

Study Arms (2)

Docetaxel Weekly

EXPERIMENTAL

Arm I: Docetaxel IV over 1 hour on day 1. Courses repeat every 21 days.

Drug: Docetaxel

Docetaxel Every 3 Weeks

EXPERIMENTAL

Arm II: Docetaxel IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days.

Drug: Docetaxel

Interventions

DocetaxelDRUG

Every 3 weeks at a starting dose of 75 mg/m2 IV over 1 hour on day 1, repeated every 21 days.

Also known as: Taxotere
Docetaxel Every 3 Weeks

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

MD Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

University of Texas M.D. Anderson CCOP Research Base

Houston, Texas, 77030-4009, United States

Location

Related Publications (1)

  • 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.

    PMID: 18300256RESULT

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Edgardo Rivera, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2001

First Posted

January 27, 2003

Study Start

December 1, 1999

Primary Completion

March 1, 2006

Study Completion

January 1, 2007

Last Updated

July 30, 2012

Record last verified: 2012-07

Locations

US(2)