Clinical trial NCT00004115: Monoclonal Antibody Therapy in Treating Patients With Ovarian Cancer or Primary Peritoneal Cancer in Remission Following Surgery and Chemotherapy
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Antisoma
state: England
Study officials:
affiliation: Jonsson Comprehensive Cancer Center
name: Jonathan S. Berek, MD
role: STUDY_CHAIR
References: