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Sponsors and Collaborators: |
California Cancer Consortium National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00118144 |
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well bortezomib works in treating patients with stage IIIB or stage IV lung cancer.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: bortezomib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of Bortezomib (PS-341) For Patients With Advanced Bronchiolo-Aveolar Carcinoma (BAC) or Adencarcinoma With BAC Features |
Estimated Enrollment: | 74 |
Study Start Date: | June 2005 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to prior epidermal growth factor receptor inhibitor therapy (yes vs no).
Patients receive bortezomib IV over 3-5 seconds on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for survival.
PROJECTED ACCRUAL: A total of 24-74 patients (12-37 per stratum) will be accrued for this study within 8-24 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed bronchoalveolar carcinoma (BAC) or adenocarcinoma of the lung with BAC features
Stage IIIB or IV disease
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
No unstable brain metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
No more than 1 prior chemotherapy regimen for advanced BAC
Endocrine therapy
Radiotherapy
Surgery
Other
United States, California | |
City of Hope Comprehensive Cancer Center | Recruiting |
Duarte, California, United States, 91010-3000 | |
Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen 800-826-4673 becomingapatient@coh.org | |
Contra Costa Regional Medical Center | Recruiting |
Martinez, California, United States, 94553 | |
Contact: Sharon Hiner, MD 925-370-5114 shiner@hsd.co.contra-costa.ca.us | |
University of California Davis Cancer Center | Recruiting |
Sacramento, California, United States, 95817 | |
Contact: Clinical Trials Office - University of California Davis Cancer 916-734-3089 | |
USC/Norris Comprehensive Cancer Center and Hospital | Recruiting |
Los Angeles, California, United States, 90089-9181 | |
Contact: Barbara J. Gitlitz, MD 323-865-3959 | |
Veterans Affairs Outpatient Clinic - Martinez | Recruiting |
Martinez, California, United States, 94553 | |
Contact: Ted Wun, MD 925-372-2062 | |
United States, Illinois | |
University of Chicago Cancer Research Center | Recruiting |
Chicago, Illinois, United States, 60637-1470 | |
Contact: Everett E. Vokes, MD 773-702-9306 evokes@medicine.bsd.uchicago.edu | |
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | Recruiting |
Detroit, Michigan, United States, 48201-1379 | |
Contact: Patricia M. LoRusso, DO 313-745-8860 | |
United States, Ohio | |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Recruiting |
Columbus, Ohio, United States, 43210-1240 | |
Contact: Clinical Trials Office - OSU Comprehensive Cancer Center 614-293-4976 osu@emergingmed.com | |
United States, Pennsylvania | |
Penn State Cancer Institute at Milton S. Hershey Medical Center | Recruiting |
Hershey, Pennsylvania, United States, 17033-0850 | |
Contact: Clinical Trials Office - Penn State Cancer Institute at Milton 717-531-3779 CTO@hmc.psu.edu | |
UPMC Cancer Centers | Recruiting |
Pittsburgh, Pennsylvania, United States, 15232 | |
Contact: Clinical Trials Office - UPMC Cancer Centers 412-647-8073 | |
United States, Wisconsin | |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Recruiting |
Madison, Wisconsin, United States, 53792-6164 | |
Contact: Clinical Trials Office - University of Wisconsin Paul P. Carbo 608-262-5223 |
Study Chair: | David R. Gandara, MD | University of California, Davis |
Investigator: | Suresh Ramalingam, MD | UPMC Cancer Centers |
Study ID Numbers: | CDR0000433404, CCC-PHII-57, NCI-7003, UPCI-04163 |
Study First Received: | July 8, 2005 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00118144 |
Health Authority: | Unspecified |
stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer recurrent non-small cell lung cancer bronchoalveolar cell lung cancer adenocarcinoma of the lung |
Thoracic Neoplasms Non-small cell lung cancer Adenocarcinoma of lung Respiratory Tract Diseases Adenocarcinoma, Bronchiolo-Alveolar Lung Neoplasms |
Lung Diseases Bortezomib Adenocarcinoma Carcinoma, Non-Small-Cell Lung Recurrence Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Pharmacologic Actions Protease Inhibitors |