NCT00004115

Monoclonal Antibody Therapy in Treating Patients With Ovarian Cancer or Primary Peritoneal Cancer in Remission Following Surgery and Chemotherapy

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: —
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Ovarian Cancer
• Primary Peritoneal Cavity Cancer

Interventions

Type	Name	Description
RADIATION	yttrium Y 90 monoclonal antibody HMFG1

Timeline

• Start date: 1998-12-01
• First posted: 2003-01-27
• Last updated: 2013-09-17

Locations

1 site across 1 country: United Kingdom