A Phase II Trial of Docetaxel Plus Cetuximab and Docetaxel Plus Bortezomib (NSC #681239, IND #58443) in Advanced Non-Small Cell Lung Cancer Patients With Performance Status (PS) 2
I. To evaluate the progression free survival (PFS), defined as the time between study entry
and disease progression or death, for each of the two combination regimens.
I. To determine the overall response rate of each regimen. II. To evaluate the overall
survival distributions associated with each regimen.
III. To evaluate the toxicities of each regimen.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
Arm I: Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and cetuximab IV
over 1-2 hours on days 1, 8, 15, and 22. Treatment repeats every 28 days for 4 courses in
the absence of disease progression or unacceptable toxicity. Patients with responding or
stable disease after 4 courses receive cetuximab alone as above 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 1,
8, and 15. Treatment repeats every 28 days for 4 courses in the absence of disease
progression or unacceptable toxicity. Patients with responding or stable disease after 4
courses receive bortezomib alone as above in the absence of disease progression or
After completion of study treatment, patients are followed monthly for 1 year, every 2
months for 2 years, and then every 4 months for 3 years.
PROJECTED ACCRUAL: A total of 62 patients (31 per treatment arm) will be accrued for this
study within 6-11 months.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The product limit estimator developed by Kaplan and Meier will be used.
Time between randomization and initial failure (disease progression or death), assessed up to 6 months
Cancer and Leukemia Group B
United States: Food and Drug Administration
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