PS-341 in Treating Patients With Metastatic Kidney Cancer
A Phase II Trial of PS-341 in Patients With Renal Cell Cancer
3 other identifiers
interventional
23
1 country
10
Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of PS-341 is more effective in treating metastatic kidney cancer. PURPOSE: Randomized phase III trial to study the effectiveness of PS-341 in treating patients who have metastatic kidney cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2001
Typical duration for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2001
CompletedFirst Submitted
Initial submission to the registry
October 11, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2002
CompletedFirst Posted
Study publicly available on registry
June 17, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedSeptember 5, 2013
September 1, 2013
11 months
October 11, 2001
September 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response Rate of PS-341 in colon cancer
9 weeks
Study Arms (2)
Pre-Treatment biopsy followed by PS-341 administration
EXPERIMENTALPre-treatment tumor biopsy followed by 3 cycles of PS-341 given by IV infusion. Each cycle will last 3 weeks. PS-341 will be given 2 times a week for 2 weeks followed by a 'rest' week with no drug. After the 3rd cycle, subjects can continue to receive another 3 cycles of the study drug if their disease has not worsened.
PS-341 administration followed by biopsy
EXPERIMENTAL3 cycles of PS-341 given by IV infusion. Each cycle will last 3 weeks. PS-341 will be given 2 times a week for 2 weeks followed by a 'rest' week with no drug. After the 3rd cycle, subjects will have a tumor biopsy and can continue to receive another 3 cycles of the study drug if their disease has not worsened.
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- University of Chicagolead
- National Cancer Institute (NCI)collaborator
Study Sites (10)
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470, United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640, United States
Cancer Care Specialists of Central Illinois, S.C.
Decatur, Illinois, 62526, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
LaGrange Memorial Hospital
LaGrange, Illinois, 60525, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, 61602, United States
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne, Indiana, 46885-5099, United States
Michiana Hematology/Oncology P.C.
South Bend, Indiana, 46617, United States
Oncology Care Associates, P.L.L.C.
Saint Joseph, Michigan, 49085, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Walter M. Stadler, MD, FACP
University of Chicago
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2001
First Posted
June 17, 2003
Study Start
October 1, 2001
Primary Completion
September 1, 2002
Study Completion
March 1, 2006
Last Updated
September 5, 2013
Record last verified: 2013-09