Bortezomib in Treating Patients With Advanced or Metastatic Sarcoma
- Conditions
- Sarcoma
- Registration Number
- NCT00027716
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Brief Summary
RATIONALE: Bortezomib may stop the growth of cancer by blocking the enzymes necessary for tumor cell growth.
PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have advanced or metastatic sarcoma.
- Detailed Description
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.)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
University of Colorado Cancer Center at University of Colorado Health Sciences Center
🇺🇸Aurora, Colorado, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Albert Einstein College of Medicine
🇺🇸Bronx, New York, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
University of Chicago Cancer Research Center
🇺🇸New York, New York, United States
Abramson Cancer Center at University of Pennsylvania Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center🇺🇸Aurora, Colorado, United States