Clinical trial NCT00193180: Docetaxel Plus Imatinib Mesylate in Metastatic Breast Cancer
Official title: Phase II Trial of Docetaxel Plus Imatinib Mesylate in Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Breast Cancer
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: Novartis
name: Aventis Pharmaceuticals
First posted: 2005-09-19
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: 18 months
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: 18 months
measure: Overall Survival (OS)
timeFrame: 18 months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Northeast Georgia Medical Center
state: Georgia
city: Louisville
country: United States
facility: Consultants in Blood Disorders and Cancer
state: Kentucky
city: Baton Rouge
country: United States
facility: Baton Rouge General Medical Center
state: Louisiana
city: Omaha
country: United States
facility: Methodist Cancer Center
state: Nebraska
city: Cincinnati
country: United States
facility: Oncology Hematology Care
state: Ohio
city: Nashville
country: United States
facility: Tennessee Oncology
state: Tennessee
Study officials:
affiliation: SCRI Development Innovations, LLC
name: Denise A. Yardley, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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):237-42. doi: 10.3816/CBC.2009.n.040.