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Phase 2
18 Years
Not Enrolling
Ovarian Neoplasms

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Trial Information

Inclusion Criteria

Inclusion Criteria

- Histological diagnosis of epithelial adenocarcinoma of ovarian, tubal or peritoneal
origin and disease is classified as FIGO Stage III or IV.

- Functional Performance Status < or = 2 by ECOG scale or > or = 60% on Karnofsky

- Medical assessment consistent with prognosis for an expected survival of at least 6

- Serum CA125 level >35 U/mL prior to or at initial surgery. Alternatively, serum CA125
level > or = 100 U/mL and immunohistochemical evidence of tumor tissue expressing

- Presence of residual disease that is either (a) visible to or palpable by the surgeon
at the completion of the staging laparotomy procedure, or (b) microscopic disease
remaining following the staging laparotomy procedure.

- Received chemotherapy that included cisplatin or carboplatin following appropriate
staging procedure.

- Complete clinical response to primary treatment protocol, which included laparotomy
followed by platinum-based adjuvant chemotherapy.

Exclusion Criteria:

- First dose of study medication must be within 10 weeks of completing last dose of
primary chemotherapy.

- Not more than one prior regimen of chemotherapy. A change of chemotherapy agents is
permitted during the patient's primary therapy provided that the change is considered
to be part of the initial chemotherapy treatment regimen.

- No whole abdomen, abdominopelvic or pelvic radiotherapy, surgery or chemotherapy
within 4 weeks prior to first dose of study drug.

- No immunotherapy (interferons, tumor necrosis factor, other cytokines or biological
response modifiers, or BCG vaccines) within the previous 6 weeks of first study dose.
Patients who have received hemopoietic factors are acceptable.

- No previous treatment with murine monoclonal antibodies for diagnostic or therapeutic

- No compromised hematopoietic function defined as a hemoglobin <8.0 g/dL or lymphocyte
count <300 mm3 or neutrophil count <1000 mm3 or platelet count <100,000 mm3.

- No hepatic dysfunction defined as a bilirubin >1.5 times the upper normal limits.

- No severe renal dysfunction defined as serum creatinine >1.6 mg/dL.

- While pregnancy is unlikely in view of the disease and previous surgery, patients who
the investigator considers may be at risk of pregnancy will have a pregnancy
[beta-HCG] test and will be using a medically approved contraceptive method. Patients
who are breast-feeding are also excluded.

- No active autoimmune disease (e.g., rheumatoid arthritis, SLE, ulcerative colitis,
Chrohn?s Disease, MS, ankylosing spondylitis).

- No known allergy to murine proteins, or prior documented anaphylactic reaction to any

- Not on chronic treatment with immunosuppressive drugs such as cyclosporin, ACTH, or

- No active infection causing fever.

- No previous splenectomy.

- No recognized immunodeficiency disease including cellular immunodeficiencies,
hypogammaglobulinemia or dysgammaglobulinemia; no acquired, hereditary, or congenital

- No uncontrolled diseases or illness other than this cancer. Patients with chronic
diseases that are well controlled (e.g., diabetes mellitus, hypertension) are

- No significant cardiovascular abnormalities (uncontrolled hypertension, CHF (NYHA
Classes II-IV), uncontrolled angina, or uncontrolled arrhythmias).

- No concurrent illness or chronically taking medication that could confound the
results of the study, preclude the patient from completing the study or mask an
adverse reaction.

- No concurrent malignancy (except non-melanoma of the skin or in situ carcinoma of
cervix), unless curative treatment was received and patient has been disease-free for
> or = 5 years.

- No other investigational drugs within 30 days of enrollment.

- No contraindications present to the use of pressor agents.

- Inability to read or understand, and/or unwilling to sign a written consent form
which must be obtained prior to treatment.

- Only tumors of low malignant potential or with noninvasive disease.

- Not more than one interval debulking procedure.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


United States: Food and Drug Administration

Study ID:




Start Date:

September 2000

Completion Date:

December 2007

Related Keywords:

  • Ovarian Neoplasms
  • immunotherapy
  • monoclonal
  • antibody
  • Stage III ovarian epithelial cancer
  • Stage IV ovarian epithelial cancer
  • Neoplasms
  • Ovarian Neoplasms



Roswell Park Cancer Institute Buffalo, New York  14263
Stanford University Medical Center Stanford, California  94305-5408
University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
Texas Oncology, P.A. Dallas, Texas  75246
University of Texas Southwestern Medical Center at Dallas Dallas, Texas  75235-8897
Walt Disney Memorial Cancer Institute Orlando, Florida  32803
Ellis Fischel Cancer Center Columbia, Missouri  65203
Gynecologic Oncology Associates Newport Beach, California  92663
Baptist Hospital of East Tennessee Knoxville, Tennessee  37920
St. Joseph's Regional Medical Center South Bend, Indiana  46617
Parker Hill Oncology & Hematology Boston, Massachusetts  02120
Swedish Medical Center Tumor Institute Seattle, Washington  98104