Trials / Completed

CompletedNCT00237627

Doxorubicin Hydrochloride Liposome and Bortezomib in Treating Patients With Refractory Hematologic Cancer or Malignant Solid Tumor or Metastatic Breast Cancer

A Phase I Evaluation of the Combination of Pegylated Liposomal Doxorubicin (Doxil®) With PS-341 in Patients With Refractory Hematologic and Solid Malignancies

Status: Completed
Phase: Phase 1 / Phase 2
Study type: Interventional
Enrollment: 107 (actual)

Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving doxorubicin hydrochloride liposome together with bortezomib may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of bortezomib when given together with doxorubicin hydrochloride liposome and to see how well they work in treating patients with refractory hematologic cancer or malignant solid tumor or metastatic breast cancer.

Detailed description

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.

Conditions

Interventions

Type	Name	Description
DRUG	PS-341	PS-341 will be administered as an intravenous push into a side arm of either a peripheral or central intravenous line infusing normal saline at 100 ml/hr. Patients will be treated twice weekly for two weeks, followed by a one week rest period, such that the typical days of treatment will be days 1, 4, 8, 11 of each three-week cycle. The initial dose level for PS-341 will be 0.9 mg/m2/dose intravenously, while subsequent dose levels will be determined according to a modified Fibonacci schema
DRUG	Doxil	Doxil will be administered at a dose of 30 mg/m2 as a 1 hour infusion through either a peripheral or central intravenous line every 3 weeks (on day 4 of each 21 day cycle)
DRUG	Velcade	Velcade will be adminstered intravenously at 1.3 mg/m2 days 1, 4, 8, 11 every 3 weeks

Timeline

Start date: 2001-05-01
Primary completion: 2006-12-01
Completion: 2010-01-01
First posted: 2005-10-12
Last updated: 2012-05-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00237627. Inclusion in this directory is not an endorsement.