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
OSI Pharmaceuticals
With
OBJECTIVES: * Determine the maximum tolerated dose of erlotinib in combination with gemcitabine in patients with recently diagnosed, gemcitabine-naive, locally advanced or metastatic pancreatic carcinoma or other potentially responsive solid tumor. * Determine the safety and tolerability of this regimen in these patients. * Determine the pharmacokinetics of this regimen in these patients. * Determine the objective antitumor response rate and response duration in patients treated with this regimen. * Determine the time to disease progression and duration of overall survival in patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of erlotinib. Patients receive gemcitabine IV over 30 minutes on day 1 of weeks 1-7 and oral erlotinib once daily beginning on day 3 of week 1 and continuing for 8 weeks (course 1). Patients receive subsequent courses of therapy comprising gemcitabine once weekly for 3 weeks and erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of erlotinib 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. Once the MTD is determined, 12 additional patients are accrued and treated at the MTD as above. Patients are followed at 30 days. PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study within 3 months.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
