Phase 2 Study of VELCADE Alone or VELCADE® Plus Docetaxel in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer
A Randomized, Multicenter, Open-Label, Phase 2 Study of VELCADE Alone or VELCADE Plus Docetaxel in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer
1 other identifier
interventional
155
1 country
20
Brief Summary
The purpose of this study is to evaluate how tumors in patients with non-small cell lung cancer respond to treatment with VELCADE alone versus VELCADE given with docetaxel and also to see what effects (good and bad) it has on you and your cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 nonsmall-cell-lung-cancer
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2002
CompletedFirst Submitted
Initial submission to the registry
January 21, 2003
CompletedFirst Posted
Study publicly available on registry
January 22, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2004
CompletedFebruary 11, 2008
February 1, 2008
1.8 years
January 21, 2003
February 7, 2008
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- Inoperable, locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC that has been histologically or cytologically confirmed.
- No more than 1 prior chemotherapy regimen.
- years of age or older.
- Measurable or evaluable disease.
- KPS ≥70%.
- Life expectancy greater than 3 months.
- Female patient is either post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control for the duration of the study.
- Male patient agrees to use an acceptable method of birth control for the duration of the study.
- Provide written informed consent before any study-related procedure not part of normal medical care is conducted.
- Willing and able to comply with the protocol requirements.
You may not qualify if:
- Peripheral neuropathy of Grade 2 or greater intensity, as defined by the NCI Common Toxicity Criteria (CTC):
- Grade 2: Objective sensory loss or paresthesia (including tingling), interfering with function, but not interfering with activities of daily living (ADLs).
- Grade 3: Sensory loss or paresthesia interfering with ADLs.
- Grade 4: Permanent sensory loss that interferes with function.
- Previous treatment with VELCADE.
- Previous treatment with docetaxel (prior treatment with paclitaxel will be allowed).
- Chemotherapy within 4 weeks prior to enrollment.
- Radiation therapy within 4 weeks prior to enrollment.
- Monoclonal antibodies within 6 weeks prior to enrollment.
- Any major surgery within 4 weeks prior to enrollment.
- Inadequate organ function at the Screening visit as defined by the following laboratory values:
- Platelet count ≤100,000 x 109/L
- Hemoglobin ≤8.0 g/dL
- Absolute neutrophil count (ANC) ≤1.5 x 109/L
- Aspartate transaminase (AST) ≥3 x the upper limit of the normal range (ULN)
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
U of Alambama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294, United States
Cedars-Sinai Comprehensive Cancer Center
Los Angeles, California, 90048, United States
UCLA Medical Center Thoracic Malignancy
Los Angeles, California, 90095, United States
University of Colorado Health Sciences Center
Aurora, Colorado, 80010, United States
Yale University School Of Medicine
New Haven, Connecticut, 06520, United States
Univeristy of Florida Shands Cancer Center
Gainesville, Florida, 32610, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Atlanta VAMC
Decatur, Georgia, 30033, United States
Mass. General Hospital Hem/Onc. Associates
Boston, Massachusetts, 02114, United States
DBA Kansas City Cancer Centers
Kansas City, Missouri, 64154, United States
St. Louis University Health Sciences Center
St Louis, Missouri, 63110, United States
Washington University, Barnard Cancer Center
St Louis, Missouri, 63110, United States
Carolinas Hematology-Oncology Associates
Charlotte, North Carolina, 28203, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Kimmel Cancer Center at Jefferson
Philadelphia, Pennsylvania, 19107, United States
Vanderbilt University-Clinical Trials Center
Nashville, Tennessee, 37232, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Hunstman Cancer Institute-University of Utah
Salt Lake City, Utah, 84112, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 21, 2003
First Posted
January 22, 2003
Study Start
December 1, 2002
Primary Completion
September 1, 2004
Last Updated
February 11, 2008
Record last verified: 2008-02