Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2025-12-26 @ 4:56 AM
Study NCT ID:
NCT00045461
Status:
UNKNOWN
Last Update Posted:
2013-08-07
First Post:
2002-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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:
Study Overview
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
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 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.
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.
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?: