Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004115
Status:
UNKNOWN
Last Update Posted:
2013-09-17
First Post:
1999-12-10
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Ovarian Cancer or Primary Peritoneal Cancer in Remission Following Surgery and Chemotherapy
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Multicenter Randomized Survival Study of Monoclonal Antibody Radioimmunotherapy A Multinational Study in Patients With Ovarian Carcinoma Using the HMFG1 Antibody Labeled With 90Yttrium
Status:
UNKNOWN
Status Verified Date:
2003-04
Last Known Status:
ACTIVE_NOT_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 Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells It is not yet known whether monoclonal antibody therapy is more effective than observation for ovarian cancer or primary peritoneal cancer that is in remission
PURPOSE Randomized phase III trial to compare the effectiveness of monoclonal antibody therapy with that of observation in treating patients who have ovarian cancer or primary peritoneal cancer in remission following surgery and chemotherapy
PURPOSE Randomized phase III trial to compare the effectiveness of monoclonal antibody therapy with that of observation in treating patients who have ovarian cancer or primary peritoneal cancer in remission following surgery and chemotherapy
Detailed Description:
OBJECTIVES
Determine the efficacy of yttrium Y 90 monoclonal antibody HMFG1 in terms of survival in patients with ovarian epithelial carcinoma in remission after debulking surgery and platinum-based chemotherapy
Determine the toxicity and tolerability of this treatment regimen in these patients
Determine the quality of life of patients treated with this regimen
Evaluate this treatment regimen in terms of the time to relapse ECOG performance status frequency of hospitalization changes in concurrent medication and incidence and severity of adverse events in this patient population
OUTLINE This is a randomized parallel multicenter study Patients are randomized to one of two treatment arms
Arm I Patients receive standard therapy observation
Arm II After imaging studies of the peritoneal cavity to verify adequate fluid distribution patients receive yttrium Y 90 monoclonal antibody HMFG1 intraperitoneally over 1 minute
Quality of life is assessed in all patients prior to randomization at weeks 4 and 8 at 3 months and then every 3 months thereafter
Patients in arm I are followed at weeks 1 4 and 8 Patients in arm II are followed weekly for 6 weeks and at weeks 8 and 12 All patients are followed every 3 months for 3 years
PROJECTED ACCRUAL A total of 420 patients 210 per treatment arm will be accrued for this study
Determine the efficacy of yttrium Y 90 monoclonal antibody HMFG1 in terms of survival in patients with ovarian epithelial carcinoma in remission after debulking surgery and platinum-based chemotherapy
Determine the toxicity and tolerability of this treatment regimen in these patients
Determine the quality of life of patients treated with this regimen
Evaluate this treatment regimen in terms of the time to relapse ECOG performance status frequency of hospitalization changes in concurrent medication and incidence and severity of adverse events in this patient population
OUTLINE This is a randomized parallel multicenter study Patients are randomized to one of two treatment arms
Arm I Patients receive standard therapy observation
Arm II After imaging studies of the peritoneal cavity to verify adequate fluid distribution patients receive yttrium Y 90 monoclonal antibody HMFG1 intraperitoneally over 1 minute
Quality of life is assessed in all patients prior to randomization at weeks 4 and 8 at 3 months and then every 3 months thereafter
Patients in arm I are followed at weeks 1 4 and 8 Patients in arm II are followed weekly for 6 weeks and at weeks 8 and 12 All patients are followed every 3 months for 3 years
PROJECTED ACCRUAL A total of 420 patients 210 per treatment arm will be accrued for this study
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 |
|---|---|---|---|
| NCI-G99-1604 | None | None | None |
| UCLA-9712040 | None | None | None |
| ANTISOMA-SMART22 | None | None | None |