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Status unknownNCT00004115Updated Sep 17, 2013

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

A Phase 3 interventional study of yttrium Y 90 monoclonal antibody HMFG1 in Ovarian Cancer and Primary Peritoneal Cavity Cancer, sponsored by Jonsson Comprehensive Cancer Center. Status unknown at 1 site in United Kingdom. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-09-17.

Sponsored by Jonsson Comprehensive Cancer Center · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2003), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Allocation
Randomized
Ages
18 Years and older
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer

Keywords

  • stage I ovarian epithelial cancer
  • stage II ovarian epithelial cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • primary peritoneal cavity cancer
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In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

Browse Ovarian Neoplasms studies →

Lead sponsor

Jonsson Comprehensive Cancer Center is the lead sponsor of 396 studies on the registry; 67 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 2 (5%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior murine antibody

Chemotherapy:

  • See Disease Characteristics
  • No more than 4-8 weeks since prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • See Disease Characteristics

Other:

  • No concurrent participation in other trials involving adjuvant cancer treatment
  • No other concurrent experimental therapies
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized

Interventions

  • Radiationyttrium Y 90 monoclonal antibody HMFG1
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Study locations

1 site
  • Antisoma
    London, England W5 3QR, United Kingdom
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00004115
Lead sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
First posted
Jan 27, 2003
Start date
Dec 1998
Last update
Sep 17, 2013

Study contacts

Jonathan S. Berek, MD
study chair · Jonsson Comprehensive Cancer Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2003. You cannot join it, but the record below documents what was studied.

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