Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Alliance for Clinical Trials in Oncology
With
OBJECTIVES: Primary * Compare the efficacy of carboplatin and gemcitabine with celecoxib and/or zileuton, in terms of 7-month progression-free survival, in patients with advanced non-small cell lung cancer. Secondary * Compare the response rate, distribution of survival, and failure-free survival time of patients treated with these regimens. * Correlate CYFRA and serum vascular endothelial growth factor levels with response and survival of patients treated with these regimens. * Correlate cyclo-oxygenase-2 and 5-lipoxygenase expression with survival of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms. * Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8, carboplatin IV over 30 minutes on day 1, and oral zileuton 4 times daily on days 1-21. * Arm II: Patients receive gemcitabine and carboplatin as in arm I and oral celecoxib twice daily on days 1-21. * Arm III: Patients receive gemcitabine and carboplatin as in arm I, oral celecoxib as in arm II, and oral zileuton as in arm I. In all arms, treatment repeats every 21 days for 6 courses. Patients with responding or stable disease continue courses of zileuton and/or celecoxib in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for 1 year, every 2 months for 2 years, and then every 4 months for 3 years or until disease progression. PROJECTED ACCRUAL: A total of 117 patients (39 per treatment arm) will be accrued for this study within 11-12 months.
Age
18–120
Sex
ALL
Healthy volunteers
Not accepted