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

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.