A Multi-Institutional, Open-Label, Two-Group, Phase II Study of PS-341 (LDP-341, NSC #681239) in Patients With Advanced or Metastatic Sarcoma
OBJECTIVES:
- Determine the response rate in patients with advanced or metastatic sarcoma treated
with bortezomib.
- Correlate levels of cyclins D1, E, p21 (WAF1), p27 (Kip1), mdm^2, p53, and Ki67 with
response in patients treated with this drug.
OUTLINE: This is an open-label, multicenter study. Patients are stratified according to
disease (stratum I: soft tissue sarcoma not specified in stratum II, osteogenic sarcoma
arising from soft tissues, or gastrointestinal stromal tumor vs stratum II: Ewing's sarcoma
of soft tissue or bone, rhabdomyosarcoma, or osteogenic sarcoma of bone). (Stratum I closed
to accrual as of 10/17/03.)
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat
every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for stratum I within 5-11
months and 21-41 patients will be accrued for stratum II within 10.5-22 months. (Stratum I
closed to accrual as of 10/17/03.)
Interventional
Masking: Open Label, Primary Purpose: Treatment
Robert Maki, MD, PhD
Study Chair
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
01-073
NCT00027716
October 2001
May 2004
Name | Location |
---|---|
Albert Einstein College of Medicine | Bronx, New York 10461 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver, Colorado 80010 |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
Abramson Cancer Center at University of Pennsylvania Medical Center | Philadelphia, Pennsylvania 19104 |
University of Chicago Cancer Research Center | New York, New York 10021 |