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Sponsored by: |
Millennium Pharmaceuticals, Inc. |
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Information provided by: | Millennium Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00051974 |
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.
Condition | Intervention | Phase |
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Non-Small Cell Lung Cancer |
Drug: VELCADE™ (bortezomib) for Injection (formerly PS-341) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 155 |
Study Start Date: | December 2002 |
Primary Completion Date: | September 2004 (Final data collection date for primary outcome measure) |
In this study, patients with non-small cell lung cancer that is no longer responding to standard medical treatment with another anti-cancer drug will be randomly chosen to receive treatment with VELCADE alone or VELCADE in combination with docetaxel. Patients have almost equal chance of getting into either of the two treatment arms listed above.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Peripheral neuropathy of Grade 2 or greater intensity, as defined by the NCI Common Toxicity Criteria (CTC):
Inadequate organ function at the Screening visit as defined by the following laboratory values:
Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
United States, Alabama | |
U of Alambama at Birmingham Comprehensive Cancer Center | |
Birmingham, Alabama, United States, 35294 | |
United States, California | |
Cedars-Sinai Comprehensive Cancer Center | |
Los Angeles, California, United States, 90048 | |
UCLA Medical Center Thoracic Malignancy | |
Los Angeles, California, United States, 90095 | |
United States, Colorado | |
University of Colorado Health Sciences Center | |
Aurora, Colorado, United States, 80010 | |
United States, Connecticut | |
Yale University School Of Medicine | |
New Haven, Connecticut, United States, 06520 | |
United States, Florida | |
Sylvester Comprehensive Cancer Center | |
Miami, Florida, United States, 33136 | |
Univeristy of Florida Shands Cancer Center | |
Gainesville, Florida, United States, 32610 | |
United States, Georgia | |
Winship Cancer Institute | |
Atlanta, Georgia, United States, 30322 | |
Atlanta VAMC | |
Decatur, Georgia, United States, 30033 | |
United States, Massachusetts | |
Mass. General Hospital Hem/Onc. Associates | |
Boston, Massachusetts, United States, 02114 | |
United States, Missouri | |
DBA Kansas City Cancer Centers | |
Kansas City, Missouri, United States, 64154 | |
St. Louis University Health Sciences Center | |
St. Louis, Missouri, United States, 63110 | |
Washington University, Barnard Cancer Center | |
St. Louis, Missouri, United States, 63110 | |
United States, North Carolina | |
Carolinas Hematology-Oncology Associates | |
Charlotte, North Carolina, United States, 28203 | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 | |
United States, Pennsylvania | |
Kimmel Cancer Center at Jefferson | |
Philadelphia, Pennsylvania, United States, 19107 | |
United States, Tennessee | |
Vanderbilt University-Clinical Trials Center | |
Nashville, Tennessee, United States, 37232 | |
United States, Texas | |
University of Texas MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 | |
United States, Utah | |
Hunstman Cancer Institute-University of Utah | |
Salt Lake City, Utah, United States, 84112 | |
United States, Wisconsin | |
University of Wisconsin Comprehensive Cancer Center | |
Madison, Wisconsin, United States, 53792 |
Study ID Numbers: | M34102-048 |
Study First Received: | January 21, 2003 |
Last Updated: | February 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00051974 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Docetaxel Thoracic Neoplasms Respiratory Tract Diseases Lung Neoplasms Lung Diseases Bortezomib |
Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Protease Inhibitors Neoplasms, Glandular and Epithelial Carcinoma |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Bortezomib Enzyme Inhibitors Pharmacologic Actions Protease Inhibitors |
Carcinoma Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |