A Phase II Study of Prophylactic Radiation Therapy for the Prevention of Hemoptysis in Advanced Non Small Cell Lung Cancer in Combination With Bevacizumab, Paclitaxel, and Carboplatin in Patients at High Risk for Bevacizumab-Associated Hemoptysis
PRIMARY OBJECTIVES:
I. Evaluate the safety of prophylactic chest radiotherapy, bevacizumab, paclitaxel, and
carboplatin in patients with unresectable stage IIIB or IV non-small cell lung cancer at
high risk for bevacizumab-associated hemoptysis.
SECONDARY OBJECTIVES:
I. Assess progression-free survival of patients treated with this regimen. II. Assess the
rate of objective response, overall survival, time to response, and response duration in
irradiated lesions and non-irradiated lesions in these patients.
OUTLINE: This is an open-label, pilot, multicenter study. Patients are assigned sequentially
to 1 of 2 treatment strata.
Stratum I: Patients undergo prophylactic radiotherapy on days 1-5 and 8-12. Patients receive
paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 15. Patients also
receive paclitaxel IV over 3 hours or carboplatin IV over 30-60 minutes and bevacizumab IV
over 30-90 minutes on day 36 (course 2).
Stratum II: Patients undergo prophylactic radiotherapy and receive paclitaxel and
carboplatin as in stratum I. Patients also receive bevacizumab IV over 30-90 minutes on day
15 (course 1). In both strata, treatment with paclitaxel, carboplatin, and bevacizumab
repeats every 21 days for 5-6 courses in the absence of disease progression or unacceptable
toxicity. Patients with complete or partial response or stable disease may continue to
receive single-agent bevacizumab every 21 days in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 12 months.
PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety of treatment as measured by the incidence of grade 3-5 hemoptysis, as assessed by NCI CTCAE version 3.0
All toxicities will be tabulated.
Up to 12 months after completion of treatment
Yes
Zelanna Goldberg
Principal Investigator
California Cancer Consortium
United States: Food and Drug Administration
NCI-2012-02704
NCT00387374
October 2006
Name | Location |
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California Cancer Consortium | Duarte, California 90033 |