A Phase 1/2 interventional study of PS-341 and Doxil in Breast Cancer, Leukemia and Lymphoma, sponsored by UNC Lineberger Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-05-18.
Sponsored by UNC Lineberger Comprehensive Cancer Center · Phase 1/2, Interventional, and Treatment
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.
OBJECTIVES:
Primary
Secondary
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.
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 107 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →UNC Lineberger Comprehensive Cancer Center is the lead sponsor of 414 studies on the registry; 96 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 25 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Phase I (closed to accrual as of 10/15/2007)
Histologically or cytologically confirmed solid tumor or hematologic malignancy, including, but not limited to, any of the following:
Must meet 1 of the following criteria:
No clinically or radiographically significant pleural or pericardial effusion
Phase II
Diagnosis of breast cancer
No symptomatic brain metastases
PATIENT CHARACTERISTICS:
Phase I (closed to accrual as of 10/15/2007)
Prothrombin time (PT) and activated partial thromboplastin time (aPTT) \< 1.5 times ULN
No uncontrolled infection
No prior hypersensitivity reaction to pegylated doxorubicin hydrochloride liposome or doxorubicin hydrochloride
Phase II
No evidence of acute ischemia or active conduction system abnormalities by EKG
PRIOR CONCURRENT THERAPY:
Phase I (closed to accrual as of 10/15/2007)
Phase II
Doxil + PS-341
Drug: PS-341 · Drug: Doxil
Doxil + Velcade
Drug: Doxil · Drug: Velcade
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
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)
Also known as: pegylated liposomal doxorubicin
Velcade will be adminstered intravenously at 1.3 mg/m2 days 1, 4, 8, 11 every 3 weeks
Also known as: Bortezomib
Maximum tolerated dose (MTD) of PS-341 in combination with Doxil (Phase I)
When the current dose level exceeds the MTD, the preceding dose-level will be considered to be the MTD if there have been six patients treated at that dose level. Otherwise, 3 additional patients will be treated at the presumed MTD. No further dose escalation will occur. MTD, like dose limiting toxicity (DLT), will be defined based on toxicities seen within the first cycle. Among the additional 3 patients enrolled in a cohort, if one or more DLT is observed, the MTD will be considered to have been exceeded
Time frame: 1 year
Response rate of the combination of Velcade and Doxil in patients with metastatic breast cancer
Radiographic response will be measured using RECIST criteria
Time frame: every 42 days
This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.
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UNC Lineberger Comprehensive Cancer Center