Phase II Trial of Enzastaurin Plus Carboplatin and Gemcitabine (ECoG) in Bevacizumab-Ineligible Patients and Enzastaurin Plus Carboplatin, Gemcitabine and Bevacizumab (B-ECoG) in Bevacizumab-Eligible Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
OBJECTIVES:
Primary
- Determine the progression-free survival in patients with recurrent or stage IIIB or IV
non-small cell lung cancer treated with carboplatin, gemcitabine, and enzastaurin with
or without bevacizumab.
Secondary
- Determine the toxicity of this regimen in these patients.
- Determine the overall survival in patients treated with this regimen.
- Determine the response rate in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 treatment groups based
on eligibility for bevacizumab therapy.
- Group 1 (bevacizumab-eligible): Patients receive carboplatin IV over 30 minutes and
bevacizumab IV over 30-90 minutes on day 1; gemcitabine hydrochloride IV over 30
minutes on days 1 and 8; and oral enzastaurin hydrochloride 3 or 4 times daily on days
1-21 in courses 1-6 and bevacizumab IV over 30-90 minutes on day 1 and oral enzastaurin
hydrochloride 3 times daily on days 1-21 in all subsequent courses.
- Group 2 (bevacizumab-ineligible): Patients receive carboplatin, gemcitabine
hydrochloride, and enzastaurin hydrochloride as in group 1 in courses 1-6 and
enzastaurin hydrochloride alone 3 times daily on days 1-21 in all subsequent courses.
In both groups, courses repeat every 21 days in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for up to 5 years.
PROJECTED ACCRUAL: A total of 99 patients will be accrued for this study.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Progression-free survival at 6 months (group 1)
Athanassios Argiris, MD
Study Chair
University of Pittsburgh
Unspecified
CDR0000542546
NCT00469976
June 2007
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