SU5416 and Doxorubicin in Treating Patients With Stage IIIB or Stage IV Inflammatory Breast Cancer
RATIONALE: SU5416 may stop the growth of breast cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining SU5416 with chemotherapy may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of combining SU5416 and doxorubicin in treating patients who have stage IIIB or stage IV inflammatory breast cancer.
Drug: doxorubicin hydrochloride
Procedure: conventional surgery
Radiation: radiation therapy
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Pharmacokinetic, Pharmacodynamic, and Clinical Study of the Combination of the Angiogenesis Inhibitor SU5416 and Doxorubicin in Inflammatory Breast Cancer|
- Determine the maximum tolerated dose of SU5416 and doxorubicin in patients with stage IIIB or IV inflammatory breast cancer. [ Time Frame: Treatment repeats every 21 days for 5 courses in the absence of disease progression or unacceptable toxicity. ]
|Study Start Date:||April 2000|
|Study Completion Date:||October 2003|
|Primary Completion Date:||December 2002 (Final data collection date for primary outcome measure)|
Drug: doxorubicin hydrochloride
- Determine the maximum tolerated dose of SU5416 and doxorubicin in patients with stage IIIB or IV inflammatory breast cancer.
- Determine the overall response, response rate, and progression-free survival rate of patients treated with this regimen.
- Determine the antiangiogenic effects of this regimen in these patients.
- Assess the relationship of plasma levels of these drugs with safety and efficacy in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive doxorubicin IV continuously over 72 hours on days 1-3 of course 1. For all subsequent courses, patients receive doxorubicin as in course 1 and SU5416 IV over 1 hour twice weekly (on days 1 and 4) beginning on week 2 of course 2. Treatment repeats every 21 days for 5 courses in the absence of disease progression or unacceptable toxicity. After chemotherapy, all patients undergo a modified radical mastectomy and radiotherapy to the chest wall and regional lymph nodes. Patients with estrogen or progesterone receptor positive disease receive oral tamoxifen for 5 years after radiotherapy.
Cohorts of 3-6 patients receive escalating doses of SU5416 and doxorubicin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 3 patients may be treated at that dose level.
Patients are followed every 3 months until disease progression.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 6-9 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005822
|United States, Ohio|
|Ireland Cancer Center at University Hospitals Case Medical Center|
|Cleveland, Ohio, United States, 44106-5065|
|Study Chair:||Beth A. Overmoyer, MD, FACP||Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|