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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

107

Participants

Timeline

Start Date

May 31, 2001

Primary Completion Date

December 31, 2006

Study Completion Date

January 31, 2010

Conditions
Breast CancerLeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmOvarian CancerUnspecified Adult Solid Tumor, Protocol Specific
Interventions
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

Trial Locations (1)

27599-7295

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

UNC Lineberger Comprehensive Cancer Center

OTHER

NCT00237627 - Doxorubicin Hydrochloride Liposome and Bortezomib in Treating Patients With Refractory Hematologic Cancer or Malignant Solid Tumor or Metastatic Breast Cancer | Biotech Hunter | Biotech Hunter