Bortezomib With or Without Docetaxel in Treating Patients With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer
NCT ID: NCT00064012
Last Updated: 2019-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
4 participants
INTERVENTIONAL
2003-05-31
2004-07-31
Brief Summary
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PURPOSE: Randomized phase II trial to compare the effectiveness of bortezomib with or without docetaxel in treating patients who have relapsed or refractory stage IIIB or stage IV non-small cell lung cancer.
Detailed Description
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Primary
* Compare the tumor response rates (complete and partial response) in patients with relapsed or refractory advanced non-small cell lung cancer treated with bortezomib with vs without docetaxel.
Secondary
* Compare time to progression in patients treated with these regimens.
* Compare the overall and 1-year survival of patients treated with these regimens.
* Compare the safety and tolerability of these regimens in these patients.
* Compare the pharmacokinetics and pharmacodynamics of these regimens in these patients.
* Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
* Arm II: Patients receive docetaxel IV over 1 hour on day 1 and bortezomib IV as in arm I.
In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses beyond confirmation of CR.
Quality of life is assessed on day 1 of each treatment course (before drug administration) and at 30 days after the completion of study treatment.
Patients are followed at 30 days and then every 3 months for survival.
PROJECTED ACCRUAL: A total of 155 patients (75 for arm I and 80 for arm II) will be accrued for this study within 1 year.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Velcade Alone
Velcade
bortezomib
Velcade plus Docetaxel
Velcade plus Docetaxel
bortezomib
docetaxel
Interventions
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bortezomib
docetaxel
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed non-small cell lung cancer
* Locally advanced (stage IIIB) or metastatic (stage IV) disease
* Inoperable disease
* Relapsed or refractory disease
* Received 1, and only 1, prior chemotherapy regimen for locally advanced or metastatic disease
* Measurable or evaluable disease
* No symptomatic or inadequately treated brain metastases
* No CNS disease
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Karnofsky 70-100%
Life expectancy
* More than 3 months
Hematopoietic
* Platelet count greater than 100,000/mm\^3
* Hemoglobin greater than 8.0 g/dL
* Absolute neutrophil count greater than 1,500/mm\^3
Hepatic
* AST and ALT less than 3 times upper limit of normal (ULN)
* Bilirubin less than 1.5 times ULN
* Hepatitis B surface antigen negative
* Hepatitis C negative
Renal
* Creatinine less than 1.8 mg/dL
Cardiovascular
* No myocardial infarction within the past 6 months
* No New York Heart Association class III or IV heart failure
* No uncontrolled angina
* No severe uncontrolled ventricular arrhythmias
* No electrocardiographic evidence of acute ischemia or active conduction system abnormalities
* No poorly controlled hypertension
Immunologic
* No active systemic infection requiring treatment
* No prior allergic reaction attributable to compounds containing boron or mannitol
* HIV negative
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception
* No peripheral neuropathy grade 2 or greater
* No diabetes mellitus
* No other serious medical or psychiatric condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* More than 6 weeks since prior monoclonal antibody therapy
* No concurrent routine use of colony-stimulating factors (e.g., filgrastim \[G-CSF\] or sargramostim \[GM-CSF\])
* No concurrent immunotherapy
Chemotherapy
* See Disease Characteristics
* More than 4 weeks since prior chemotherapy
* No prior docetaxel
* Prior paclitaxel allowed
* No other concurrent chemotherapy
Endocrine therapy
* No concurrent corticosteroids (e.g., prednisone or prednisolone) except dexamethasone as premedication
Radiotherapy
* More than 4 weeks since prior radiotherapy
* No concurrent radiotherapy
Surgery
* More than 4 weeks since prior major surgery
* No concurrent surgery for cancer management or treatment
Other
* More than 5 years since prior treatment for any other cancer except basal cell skin cancer or carcinoma in situ of the cervix
* More than 4 weeks since prior investigational agents
* No prior bortezomib
* No other concurrent investigational agents
* No other concurrent clinical research study participation
* No other concurrent antineoplastic therapy
* No concurrent routine use of anti-inflammatory drugs, including cyclo-oxygenase inhibitors (e.g., celecoxib or rofecoxib)
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Joan H. Schiller, MD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, United States
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States
University of Miami Sylvester Cancer Center
Miami, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
Robbinsdale, Minnesota, United States
Kansas City Cancer Centers - Central
Kansas City, Missouri, United States
Siteman Cancer Center
St Louis, Missouri, United States
St. Louis University Hospital Cancer Center
St Louis, Missouri, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Countries
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References
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Fanucchi MP, Fossella FV, Belt R, Natale R, Fidias P, Carbone DP, Govindan R, Raez LE, Robert F, Ribeiro M, Akerley W, Kelly K, Limentani SA, Crawford J, Reimers HJ, Axelrod R, Kashala O, Sheng S, Schiller JH. Randomized phase II study of bortezomib alone and bortezomib in combination with docetaxel in previously treated advanced non-small-cell lung cancer. J Clin Oncol. 2006 Nov 1;24(31):5025-33. doi: 10.1200/JCO.2006.06.1853.
Other Identifiers
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WCCC-M34102-048
Identifier Type: -
Identifier Source: secondary_id
UCLA-0301037
Identifier Type: -
Identifier Source: secondary_id
MILLENNIUM-M34102-048
Identifier Type: -
Identifier Source: secondary_id
CDR0000305974
Identifier Type: -
Identifier Source: org_study_id