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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: | NCT00362882 |
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving docetaxel together with bortezomib may kill more tumor cells. It is not yet known which schedule of docetaxel and bortezomib is more effective in treating non-small cell lung cancer.
PURPOSE: This randomized phase II trial is studying two different schedules of docetaxel and bortezomib to compare how well they work in treating patients with progressive or recurrent non-small cell lung cancer.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: bortezomib Drug: docetaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | Randomized Phase II Trial of Sequential Versus Concurrent Docetaxel and PS-341 (NSC 681239, IND 58,443) in Previously Treated Non-Small Cell Lung Cancer |
Estimated Enrollment: | 80 |
Study Start Date: | July 2006 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm I: Experimental
Patients receive docetaxel IV over 60 minutes on day 1 and bortezomib IV over 3-5 seconds on days 1 and 8. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. |
Drug: bortezomib
given IV
Drug: docetaxel
given IV
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Arm II: Experimental
Patients receive docetaxel as in arm I and bortezomib IV over 3-5 seconds on days 2 and 8. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
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Drug: bortezomib
given IV
Drug: docetaxel
given IV
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OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to ECOG performance status (0 vs 1) and number of prior chemotherapy treatments (1 vs ≥ 1). Patients are randomized to 1 of 2 treatment arms.
Tumor and blood samples are collected periodically for biomarker analysis and pharmacokinetic assays.
Immunohistochemistry is used to assess Bcl-2, Bcl-xL, Bax, and NF-kB. Immunoenzyme techniques are used to examine hypoxia-inducible factor 1 (HIF-1), OPN, vascular endothelial growth factor, and PAI-1.
After completion of study therapy, patients are followed periodically.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Progressive or recurrent NSCLC after treatment with 1 prior platinum-based chemotherapy regimen for metastatic disease
Measurable disease* with ≥ 1 unidimensionally objectively measurable lesion, including any of the following:
Measurable disease must be outside the previous radiation field or a new lesion must be present
No symptomatic or untreated brain metastasis requiring steroids
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No concurrent hormonal therapy, biologic therapy, or radiotherapy to measurable lesions
United States, California | |
City of Hope Comprehensive Cancer Center | |
Duarte, California, United States, 91010-3000 | |
City of Hope Medical Group | |
Pasadena, California, United States, 91105 | |
Tower Cancer Research Foundation | |
Beverly Hills, California, United States, 90211 | |
University of California Davis Cancer Center | |
Sacramento, California, United States, 95817 | |
USC/Norris Comprehensive Cancer Center and Hospital | |
Los Angeles, California, United States, 90089-9181 | |
Veterans Affairs Outpatient Clinic - Martinez | |
Martinez, California, United States, 94553 | |
United States, Pennsylvania | |
Penn State Cancer Institute at Milton S. Hershey Medical Center | |
Hershey, Pennsylvania, United States, 17033-0850 | |
UPMC Cancer Centers | |
Pittsburgh, Pennsylvania, United States, 15232 | |
Canada, Ontario | |
Princess Margaret Hospital | |
Toronto, Ontario, Canada, M5G 2M9 |
Study Chair: | Primo N. Lara, MD | University of California, Davis |
Responsible Party: | University of California Davis Cancer Center ( David R. Gandara ) |
Study ID Numbers: | CDR0000491470, CCC-PHII-70, NCI-7077 |
Study First Received: | August 10, 2006 |
Last Updated: | May 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00362882 History of Changes |
Health Authority: | United States: Food and Drug Administration |
recurrent non-small cell lung cancer stage IV non-small cell lung cancer |
Docetaxel Thoracic Neoplasms Respiratory Tract Diseases Lung Neoplasms Lung Diseases Bortezomib |
Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Recurrence 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 |
Docetaxel Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |