Finding studies
Finding studies
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Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Fred Hutchinson Cancer Center
OBJECTIVES: Primary * Determine the maximum tolerated dose (MTD) of erlotinib when administered in combination with docetaxel and carboplatin as front-line therapy in patients with newly diagnosed stage III or IV ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer. Secondary * Determine the toxicity of maintenance therapy with erlotinib when administered after front-line therapy in these patients. * Determine the proportion of patients who are able to receive the full schedule of treatment courses. * Determine the objective response rate in patients with measurable or evaluable disease treated with this regimen. * Determine the progression-free and overall survival of patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of erlotinib. * Front-line therapy: Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1, pegfilgrastim subcutaneously on day 2, and oral erlotinib once daily on days 3-16. Treatment repeats every 21 days for up to 6 courses. Cohorts of 5 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 5 patients experience dose-limiting toxicity. * Maintenance therapy: Beginning 3-4 weeks after the completion of front-line therapy, patients with stable or responding disease receive oral erlotinib once daily for up to 12 months. After completion of study treatment, patients are followed every 6 months for 1 year and then periodically thereafter. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
