Status:
COMPLETED
Docetaxel and Bortezomib in Treating Patients With Progressive or Recurrent Non-Small Cell Lung Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Non-small Cell Lung Cancer
Recurrent Non-small Cell Lung Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
This 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. Drugs used in ch...
Detailed Description
PRIMARY OBJECTIVE: 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 c...
Eligibility Criteria
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.
Exclusion
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00362882
Start Date
July 1 2006
End Date
July 1 2010
Last Update
December 5 2017
Active Locations (1)
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1
City of Hope Medical Center
Duarte, California, United States, 91010