Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045461
Status:
UNKNOWN
Last Update Posted:
2013-08-07
First Post:
2002-09-06
Brief Title:
Combination Chemotherapy With or Without Whole-Body Hyperthermia in Treating Patients With Recurrent Ovarian Epithelial Fallopian Tube or Peritoneal Cancer
Sponsor:
Ludwig-Maximilians - University of Munich
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase IIIII 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
Status:
UNKNOWN
Status Verified Date:
2002-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 IIIII 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
PURPOSE Randomized phase IIIII 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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20220 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000256532 | REGISTRY | None | None |