Ovarian Cancer Clinical Trial
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
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.
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.
;
Allocation: Randomized, Primary Purpose: Treatment
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