Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
UNC Lineberger Comprehensive Cancer Center
With
OBJECTIVES: Primary * Determine the maximum tolerated dose of bortezomib when administered with pegylated doxorubicin hydrochloride liposome in patients with refractory hematologic or solid tumor malignancies. (Phase I \[closed to accrual as of 10/15/2007\]) * Determine the dose-limiting toxicity of this regimen in these patients. (Phase I \[closed to accrual as of 10/15/2007\]) * Determine the response rate in patients with metastatic breast cancer treated with this regimen. (Phase II) Secondary * Determine the response in patients with hematologic or solid tumor malignancies treated with this regimen. (Phase I \[closed to accrual as of 10/15/2007\]) * Determine the time to disease progression in patients with metastatic breast cancer treated with this regimen. (Phase II) * Obtain further evidence of the safety of this regimen in patients with metastatic breast cancer. (Phase II) OUTLINE: This is a phase I (closed to accrual as of 10/15/2007), dose-escalation study of bortezomib followed by a phase II study. * Phase I (closed to accrual as of 10/15/2007): Patients receive bortezomib IV on days 1, 4, 8, and 11 and pegylated doxorubicin hydrochloride liposome IV over 1 hour on day 4. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. * Phase II: Patients receive bortezomib (at the maximum tolerated dose determined in phase I) and pegylated doxorubicin hydrochloride liposome as in phase I. After completion of study therapy, patients are followed at 1 week. PROJECTED ACCRUAL: A total of 72 patients will be accrued for the phase I portion of the study and 40 for the phase II portion.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
