Finding studies
Finding studies
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Lead
Mayo Clinic
With
OBJECTIVES: Primary * Determine the efficacy of lapatinib ditosylate and topotecan hydrochloride, in terms of response, in patients with platinum-resistant or refractory ovarian epithelial or primary peritoneal cavity carcinoma. Secondary * Determine the overall survival time in patients treated with this regimen. * Determine the time to progression in patients treated with this regimen. * Assess the toxicity profile of this regimen in these patients. Translational * Determine the expression patterns of epidermal growth factor receptor, HER2/neu, hypoxia-induced factor 1 alpha, CD31, breast cancer resistance protein, and topoisomerase I by immunohistochemistry using tumor tissue from primary debulking surgery. * Determine the feasibility of monitoring circulating tumor cells with specific biological markers to determine or follow response in these patients. OUTLINE: This is a multicenter study. Patients receive oral lapatinib ditosylate once daily on days 1-28 and topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood samples are collected at baseline and on day 8 of course 1 (immediately after the topotecan infusion) and are evaluated for pharmacological studies. Tumor tissue samples obtained at debulking surgery are examined by immunohistochemistry for epidermal growth factor receptor, HER1, ErbB1, HER2/neu, ErbB2, hypoxia-induced factor 1 alpha, CD31, platelet endothelial cell adhesion molecule 1, topoisomerase I, and breast cancer resistance protein. After the completion of study treatment, patients are followed periodically for 2 years. PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
