A Randomized Phase II/III Trial Comparing Carboplatin-Ifosfamide (IC)-Chemotherapy Vs. IC-Chemotherapy Combined With Extreme Whole Body Hyperthermia In Patients With Recurrence Of Epithelial Ovarian Carcinoma: DOLPHIN-1-STUDY
- 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
- 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
- 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.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Time to progressive disease
Harald Sommer, MD
Ludwig-Maximilians - University of Munich