Docetaxel and Bortezomib in Treating Patients With Progressive or Recurrent Non-Small Cell Lung Cancer
NCT ID: NCT00362882
Last Updated: 2017-12-05
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
81 participants
INTERVENTIONAL
2006-07-31
2010-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
I. To compare the efficacy and tolerability of sequential vs concurrent docetaxel and bortezomib in patients with previously treated, progressive or recurrent, advanced non-small cell lung cancer (NSCLC).
SECOND OBJECTIVES:
I. To compare time to progression in patients with previously treated NSCLC treated with these regimens.
II. To compare 1-year and overall survival of patients treated with these regimens.
III. To compare the toxicity of these regimens in these patients. IV. To determine the pharmacokinetics of docetaxel in the context of this study.
TERTIARY OBJECTIVE:
I. To determine levels of expression of molecular markers regulated by docetaxel and bortezomib and correlate with clinical response and overall survival of these patients.
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.
ARM I: 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.
ARM II: 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.
After completion of study therapy, patients are followed periodically.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm 1
Patients receive docetaxel IV over 60 minutes on day 1 and bortezomib IV over 3-5 seconds on days 1 and 8.
docetaxel
Given IV
bortezomib
Given IV
laboratory biomarker analysis
correlative study
immunoenzyme technique
correlative study
immunohistochemistry staining method
correlative study
pharmacological study
correlative study
Arm 2
Patients receive docetaxel as in arm I and bortezomib IV over 3-5 seconds on days 2 and 8.
docetaxel
Given IV
bortezomib
Given IV
laboratory biomarker analysis
correlative study
immunoenzyme technique
correlative study
immunohistochemistry staining method
correlative study
pharmacological study
correlative study
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
docetaxel
Given IV
bortezomib
Given IV
laboratory biomarker analysis
correlative study
immunoenzyme technique
correlative study
immunohistochemistry staining method
correlative study
pharmacological study
correlative study
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer for which the patient is currently in complete remission, or any other cancer for which the patient has been disease-free for 5 years.
* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
* Progressive or recurrent NSCLC after treatment with 1 prior platinum-based chemotherapy regimen for metastatic disease. Prior neoadjuvant/adjuvant chemotherapy and/or concurrent chemoradiation for early-stage disease allowed.
* At least 4 weeks since prior chemotherapy (6 weeks for mitomycin C or nitrosoureas) and recovered.
* No prior docetaxel or bortezomib
* Prior epidermal growth factor receptor inhibitor therapy allowed.
* Prior paclitaxel allowed
* At least 4 weeks since prior major surgery and recovered.
* At least 2 weeks since prior and no concurrent enzyme-inducing anticonvulsants.
* No concurrent hormonal therapy, biologic therapy, or radiotherapy to measurable lesions. Concurrent palliative radiotherapy to small-field nonindicator lesions (e.g., painful bony metastases) allowed.
* Measurable disease\* with \>= 1 unidimensionally objectively measurable lesion, including any of the following:
* Lung mass (measurable on chest x-ray, tomograms, or CT scan)
* Enlarged lymph nodes
* Liver metastasis (measurable as a discrete focal lesion on radionuclide or CT scan, or ultrasound)
* Metastatic abdominal mass (measurable on CT scan with \>= 1 perpendicular diameter ≥ the distance between cuts)
* Measurable disease must be outside the previous radiation field or a new lesion must be present.
* Life expectancy \>= 12 weeks
* Progressive disease within a previously radiated field allowed.
* \[Note: \*Measurable disease DOES NOT include bone metastases or non-focal liver metastases\].
* No symptomatic or untreated brain metastasis requiring steroids. Asymptomatic, previously treated (surgical resection or radiotherapy) brain metastasis allowed provided they are neurologically stable and \>= 4 weeks since prior steroids.
* Creatinine clearance \>= 50 mL/min
* Creatinine =\< 1.6 mg/dL
* Bilirubin normal
* AST =\< 2 times upper limit of normal
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No peripheral neuropathy \>= grade 2
* Absolute granulocyte count \>= 1,500/mm³
* Platelet count \>= 100,000/mm³
* Cutaneous nodule
* ECOG performance status 0-1
* At least 4 weeks since prior radiotherapy and recovered.
18 Years
120 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Primo Lara
Role: PRINCIPAL_INVESTIGATOR
University of California, Davis
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
City of Hope Medical Center
Duarte, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PHII-70
Identifier Type: -
Identifier Source: secondary_id
CDR0000491470
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-2009-00123
Identifier Type: -
Identifier Source: org_study_id