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
Masonic Cancer Center, University of Minnesota
OBJECTIVES: Primary * Determine whether at least 50% of patients with advanced ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer are able to achieve optimal cytoreduction (to \< 1 centimeter of remaining disease) after neoadjuvant chemotherapy comprising paclitaxel and carboplatin. Secondary * Determine the frequency and severity of toxicity associated with this regimen in patients who are high-risk surgical candidates or in patients unlikely to achieve optimal surgical cytoreduction. * Determine if extreme drug resistance assay profiles change after neoadjuvant chemotherapy. * Determine how thrombospondin-1 (TSP-1), tumor protein 53 (p53), and tumor vessel density change after administration of neoadjuvant chemotherapy. * Assess the quality of life of patients receiving neoadjuvant chemotherapy. * Obtain estimates of tumor response after administration of neoadjuvant chemotherapy. * Determine whether serum cancer antigen 125 (CA-125) at the time of cytoreduction is associated with the ability to optimally reduce the patients. OUTLINE: This is an open-label study. Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Within 4-6 weeks after the fourth course of chemotherapy, patients undergo interval cytoreductive surgery. Patients who are unable to undergo surgery receive 2 additional courses of chemotherapy and are re-evaluated for surgery after the sixth course of chemotherapy. Within 4 weeks after surgery, patients receive 2 additional courses of chemotherapy. Quality of life is assessed periodically. Tumor samples are obtained via laparoscopic or percutaneous biopsy prior to beginning chemotherapy and during interval cytoreduction. Tissue is examined by immunohistochemistry staining for p53, TSP-1, microvessel density (CD31), angiogenesis, membrane protein BCL-2, and multidrug resistant gene 1 (MDR-1). Gene array analysis and extreme drug resistant assays are also performed. After completion of study treatment, patients are followed every 3 months for 2 years.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
