Ovarian Cancer Clinical Trial
Official title:
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
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Hyperthermia therapy kills tumor cells by heating them to
several degrees above body temperature. Combining hyperthermia with chemotherapy may kill
more tumor cells. It is not yet known if chemotherapy is more effective with or without
whole-body hyperthermia therapy in treating gynecologic cancer.
PURPOSE: Randomized phase II/III trial to compare the effectiveness of chemotherapy with or
without whole-body hyperthermia in treating patients who have recurrent ovarian epithelial,
fallopian tube, or peritoneal cancer.
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.
;
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
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