Docetaxel Plus Imatinib Mesylate in Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193180
• Other study ID #: SCRI BRE 74
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: March 25, 2013
• Start date: May 2005
• Est. completion date: January 2009

Study information

• Verified date: March 2013
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This trial evaluates the novel combination of docetaxel with imatinib as first or second line therapy in advanced breast cancer with the aim of achieving higher effectiveness and potentially reducing side effects.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: January 2009
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Imatinib
Imatinib
• Docetaxel
Docetaxel

Locations

Country	Name	City	State
United States	Baton Rouge General Medical Center	Baton Rouge	Louisiana
United States	Oncology Hematology Care	Cincinnati	Ohio
United States	Northeast Georgia Medical Center	Gainesville	Georgia
United States	Consultants in Blood Disorders and Cancer	Louisville	Kentucky
United States	Tennessee Oncology	Nashville	Tennessee
United States	Methodist Cancer Center	Omaha	Nebraska

Sponsors (3)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	Aventis Pharmaceuticals, Novartis

Country where clinical trial is conducted

United States, 

References & Publications (1)

Yardley DA, Burris HA 3rd, Markus T, Spigel DR, Greco FA, Mainwaring M, Waterhouse DM, Webb CD, Hainsworth JD. Phase II trial of docetaxal plus imatinib mesylate in the treatment of patients with metastatic breast cancer. Clin Breast Cancer. 2009 Nov;9(4) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment		18 months	No
Secondary	Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease		18 months	No
Secondary	Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death		18 months	No