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
Ludwig-Maximilians - University of Munich
OBJECTIVES: * Compare the time to progressive disease in patients with recurrent ovarian epithelial, fallopian tube, or extraovarian peritoneal cancer treated with carboplatin and ifosfamide with or without whole body hyperthermia. * Compare the response rate, duration of response, and survival time of patients treated with these regimens. * Compare the effect on the presence of disseminated tumor cells in bone marrow in patients treated with these regimens. * Compare the toxicity of these regimens in these patients. * Assess quality of life of patients treated with these regimens. OUTLINE: This is a phase II safety and efficacy study followed by a phase III randomized, open-label, multicenter study. * Phase II: Patients receive ifosfamide IV over 1 hour and carboplatin IV over 20 minutes on day 1. Patients also undergo whole body hyperthermia for at least 1 hour on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. * Phase III (after successful treatment of 15 patients in phase II): Patients are stratified according to disease-free interval (6-12 months vs more than 12 months), measurable disease (bidimensionally measurable vs measurable by other clinical means), and disease recurrence (first recurrence vs second or greater recurrence). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive ifosfamide, carboplatin, and whole body hyperthermia as in phase II. * Arm II: Patients receive ifosfamide and carboplatin as in arm I. * In both arms, treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before each course, 4 weeks after the last course, and then every 3 months for 2 years. Patients are followed at 4 weeks and then every 3 months for 2 years. PROJECTED ACCRUAL: A total of 15 patients will be accrued for phase II of this study. A total of 226 patients (113 per treatment arm) will be accrued for phase III of this study within 2 years.
Age
18–65
Sex
FEMALE
Healthy volunteers
Not accepted
