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Phase II Trial of Docetaxel Plus Imatinib Mesylate in Metastatic Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Cancer

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Trial Information

Phase II Trial of Docetaxel Plus Imatinib Mesylate in Metastatic Breast Cancer


All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of
each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was
given at a dose of 600 mg orally daily, beginning concurrently with the first dose of
docetaxel; however, after the first 15 patients were treated it became evident that this
imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg
orally daily


Inclusion Criteria:



To be included in this study, you must meet the following criteria:

- Metastatic breast cancer confirmed by biopsy

- No more than one prior chemotherapy regimen for metastatic breast cancer

- Able to perform activities of daily living with minimal assistance

- Adequate bone marrow, liver and kidney function

- Age 18 years or older

- Give written informed consent

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

- Moderate to severe peripheral neuropathy

- Uncontrolled blood pressure or uncontrolled heart beat irregularities

- Diabetes Mellitus with fasting blood sugar greater than 200 mg %

- Significant heart disease within the prior 6 months

- Severe or uncontrolled medical disease

- Active uncontrolled infection

- Known chronic liver disease

- Known diagnosis of HIV infection

- Pregnant or breast feeding females

Please note: There are additional inclusion/exclusion criteria. The study center will
determine if you meet all of the criteria. If you do not qualify for the trial, study
personnel will explain the reasons. If you do qualify, study personnel will explain the
trial in detail and answer any questions you may have.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

Denise A. Yardley, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Institutional Review Board

Study ID:

SCRI BRE 74

NCT ID:

NCT00193180

Start Date:

May 2005

Completion Date:

January 2009

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Breast Neoplasms

Name

Location

Northeast Georgia Medical CenterGainesville, Georgia  30501
Consultants in Blood Disorders and CancerLouisville, Kentucky  40207
Baton Rouge General Medical CenterBaton Rouge, Louisiana  70821-2511
Methodist Cancer CenterOmaha, Nebraska  68114
Tennessee OncologyNashville, Tennessee  37203
Oncology Hematology CareCincinnati, Ohio  45242