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
Jonsson Comprehensive Cancer Center
With
OBJECTIVES: Primary * Determine the maximum tolerated dose of sirolimus when combined with gefitinib in patients with recurrent or refractory stage IIIB or IV non-small cell lung cancer. Secondary * Determine the overall response rate (complete response \[CR\] and partial response \[PR\]) in patients treated with this regimen. * Determine the disease control rate (CR, PR, and stable disease) in patients treated with this regimen. * Determine the time to progression and overall survival of patients treated with this regimen. * Determine the quality of life of patients treated with this regimen. OUTLINE: This is an open-label, phase I, dose-escalation study of sirolimus followed by a phase II study. * Phase I: Patients receive oral gefitinib once daily and oral sirolimus once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of sirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. * Phase II: Patients receive gefitinib and sirolimus as in phase I at the MTD. Quality of life is assessed at baseline, day 1 of each course, and then at 1 month post-progression. Patients are followed every 9 weeks. Patients withdrawn from study treatment without evidence of disease progression are followed every 6 weeks until disease progression. PROJECTED ACCRUAL: A total of 25 patients (11 for phase I and 14 for phase II) will be accrued for this study within 8.3 months.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
