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Multicenter Randomized Survival Study of Monoclonal Antibody Radioimmunotherapy: A Multinational Study in Patients With Ovarian Carcinoma Using the HMFG1 Antibody Labeled With 90Yttrium

Phase 3
18 Years
Open (Enrolling)
Ovarian Cancer, Primary Peritoneal Cavity Cancer

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Trial Information

Multicenter Randomized Survival Study of Monoclonal Antibody Radioimmunotherapy: A Multinational Study in Patients With Ovarian Carcinoma Using the HMFG1 Antibody Labeled With 90Yttrium


- 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

Inclusion Criteria


- 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



- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- At least 3 months


- WBC at least 3,000/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 10.0 g/dL


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


- Creatinine no greater than 2.0 mg/dL


- 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


Biologic therapy:

- No prior murine antibody


- See Disease Characteristics

- No more than 4-8 weeks since prior chemotherapy

Endocrine therapy:

- Not specified


- Not specified


- See Disease Characteristics


- No concurrent participation in other trials involving adjuvant cancer treatment

- No other concurrent experimental therapies

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Jonathan S. Berek, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

December 1998

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • stage I ovarian epithelial cancer
  • stage II ovarian epithelial cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms