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

Sponsor

Jonsson Comprehensive Cancer Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT00004115

Collaborator

National Cancer Institute (NCI) (NIH)

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer Primary Peritoneal Cavity Cancer	Radiation: yttrium Y 90 monoclonal antibody HMFG1	Phase 3

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Primary Purpose:

Treatment

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

Study Start Date :

Dec 1, 1998

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically proven stage IC, II, III, or IV ovarian epithelial carcinoma or primary peritoneal serous carcinoma
Prior complete response to 1 platinum-based chemotherapy regimen consisting of at least 5 courses
Absence of disease on physical and radiological exam (CT scan/MRI)
CA 125 normal
No visible evidence of malignant disease on second-look laparoscopy
No disease relapse even if complete response to a second course of chemotherapy
Prior bilateral oophorectomy with or without salpingectomy, omentectomy, and total or partial abdominal hysterectomy required
No known metastases

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

ECOG 0-2

Life expectancy:

At least 3 months

Hematopoietic:

WBC at least 3,000/mm^3
Platelet count at least 100,000/mm^3
Hemoglobin at least 10.0 g/dL

Hepatic:

SGOT/SGPT no greater than 2 times upper limit of normal

Renal:

Creatinine no greater than 2.0 mg/dL

Other:

No other malignancy except basal cell skin cancer
No serious physical or psychiatric disease that would preclude study entry
No significant loculation that would preclude good distribution of study medication
Human antimouse antibody negative