Combination Chemotherapy With or Without Whole-Body Hyperthermia in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
Recruitment status was: Recruiting
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.
Fallopian Tube Cancer
Primary Peritoneal Cavity Cancer
Procedure: hyperthermia treatment
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|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|
- Time to progressive disease [ Designated as safety issue: No ]
- Response rate [ Designated as safety issue: No ]
- Duration of response [ Designated as safety issue: No ]
- Survival time [ Designated as safety issue: No ]
- Effects on the presence of disseminated tumor cells in bone marrow [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Quality of life [ Designated as safety issue: No ]
|Study Start Date:||June 2000|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00045461
|Charite University Hospital - Campus Virchow Klinikum|
|Berlin, Germany, D-13353|
|Frankfurt, Germany, D-60488|
|University Medical Center Hamburg - Eppendorf|
|Hamburg, Germany, D-20246|
|Universitaets - Kinderklinik - Luebeck|
|Luebeck, Germany, D-23538|
|Trostberg, Germany, D-83308|
|Peterfy Korhaz Szulo-Nobeteg Oztaly|
|Budapest, Hungary, 1076|
|Academisch Medisch Centrum at University of Amsterdam|
|Amsterdam, Netherlands, 1105 AZ|
|Study Chair:||Harald Sommer, MD||Ludwig-Maximilians - University of Munich|