Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Completed 18 and over NCI, Pharmaceutical / Industry UCLA-0211008 UNITHER-OVA-Gy-17(A), NCT00050375

Objectives

1. Compare the time to disease relapse in patients with stage III or IV ovarian epithelial, fallopian tube, or peritoneal adenocarcinoma treated with monoclonal antibody B43.13 vs placebo.
2. Compare the survival of patients treated with these regimens.
3. Compare the quality of life of patients treated with these regimens.
4. Compare the immune response in patients treated with these regimens.
5. Compare the safety of these regimens in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed ovarian epithelial, fallopian tube, or peritoneal adenocarcinoma
  • Stage III or IV



• Microscopic or small-diameter residual disease after primary debulking surgery
  • No more than 1 interval debulking procedure
  • Elevated serum CA 125 prior to or at surgery
    • If pre-surgical CA 125 is not available, patients must have a serum CA 125 at least 100 U/mL and strong tumor tissue expression



• Previously treated with front-line platinum- and taxane-based chemotherapy within the past 4-12 weeks
  • Serum CA 125 level no greater than 65 U/mL prior to third course of front-line therapy
  • No more than 8 courses
  • No more than 1 prior chemotherapy regimen



• Complete clinical response to prior front-line chemotherapy and surgery, defined as the following:
  • Normal physical examination
  • No conclusive evidence of residual tumor by CT scan of the abdomen and pelvis
  • Normal chest x-ray
  • Serum CA 125 level at least 5 U/mL, but less than 35 U/mL



• No evaluable disease



• No refractory or recurrent ovarian epithelial, fallopian tube, or peritoneal adenocarcinoma requiring chemotherapy



• No tumors of low-malignant potential or noninvasive disease

Prior/Concurrent Therapy:

Biologic therapy

• More than 6 weeks since prior biological response modifiers, interferons, tumor necrosis factor, other cytokines (e.g., interleukins), or BCG vaccine
• Prior hematopoietic growth factors allowed

Chemotherapy

• See Disease Characteristics
• More than 4 weeks since prior chemotherapy
• No concurrent mercaptopurine or methotrexate
• No other concurrent anticancer chemotherapy

Endocrine therapy

• No concurrent systemic corticosteroids (e.g., dexamethasone or prednisone)
  • Inhaled corticosteroids for asthma allowed
  • Topical corticosteroids allowed
• No concurrent adrenocorticotropic hormone

Radiotherapy

• More than 4 weeks since prior radiotherapy to the whole abdomen, abdominopelvis, or pelvis

Surgery

• See Disease Characteristics
• More than 4 weeks since prior surgery
• No prior splenectomy

Other

• At least 30 days since prior investigational drugs
• No concurrent immunosuppressive drugs
• No concurrent cyclosporine
• No other concurrent antineoplastic drugs
• No concurrent azathioprine

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 6 months

Hematopoietic

• Neutrophil count at least 1,000/mm³
• Lymphocyte count at least 300/mm³
• Platelet count at least 100,000/mm³
• Hemoglobin at least 8.0 g/dL

Hepatic

• Bilirubin no greater than 5 times upper limit of normal (ULN)
• Lactate dehydrogenase no greater than 2 times ULN
• SGOT and SGPT no greater than 2 times ULN
• Albumin at least 3.5 g/dL
• No hepatitis

Renal

• Creatinine no greater than 1.6 mg/dL

Cardiovascular

• No uncontrolled hypertension
• No New York Heart Association class II-IV congestive heart failure
• No uncontrolled angina
• No uncontrolled arrhythmias
• No significant cardiovascular abnormalities

Immunologic

• HIV negative
• No immunodeficiency disease, including cellular immunodeficiencies, hypogammaglobulinema, or dysgammaglobulinema or acquired, hereditary, or congenital immunodeficiencies
• No active autoimmune disease, including any of the following:
  • Rheumatoid arthritis
  • Systemic lupus erythematosus
  • Ulcerative colitis
  • Crohn's disease
  • Multiple sclerosis
  • Ankylosing spondylitis

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other uncontrolled disease
  • Well-controlled chronic disease (e.g., diabetes mellitus or hypertension) allowed
• No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
• No contraindications to pressor agents
• No recent history of alcoholism or drug abuse
• No active febrile infection
• No known allergy to murine proteins
• No prior documented anaphylactic reaction to any drug
• No known hypersensitivity to diphenhydramine or other antihistamines of similar chemical structure
• No concurrent illness that would preclude study completion or mask an adverse reaction

Expected Enrollment

A total of 177 patients (118 for arm I and 59 for arm II) will be accrued for this study within 15 months.

Outcomes

Time to disease relapse
Survival time
Quality of life as measured by FACT-O periodically
Immunological parameters as obtained through blood samples periodically
Safety

Outline

This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive monoclonal antibody B43.13 IV over 20 minutes on weeks 0, 4, 8, and 20 and then every 12 weeks thereafter for up to 5 years from the week 0 dose.



• Arm II: Patients receive placebo IV over 20 minutes on weeks 0, 4, 8, and 20 and then every 12 weeks thereafter for up to 5 years from the week 0 dose.

Treatment in both arms continues in the absence of disease relapse or unacceptable toxicity.

Quality of life is assessed at weeks 0, 8, 20, 32, 44, 56, 68, 80, 92, and 104 and then when the patient leaves the study.

Patients are followed every 3 months for 10 years from study entry.

Trial Contact Information

Trial Lead Organizations

Jonsson Comprehensive Cancer Center at UCLA

Robin Farias-Eisner, MD, Principal investigator		Ph: 310-206-4619; 888-798-0719

Registry Information
Official Title		A Double-Blind, Placebo-Controlled, Multicenter Clinical Trial of Intravenous OvaRex® MAb-B43.13 as Post-Chemotherapy Consolidation for Epithelial Carcinoma of Ovarian, Tubal or Peritoneal Origin
Trial Start Date		2003-04-01
Registered in ClinicalTrials.gov		NCT00050375
Date Submitted to PDQ		2003-07-15
Information Last Verified		2006-04-11
NCI Grant/Contract Number		CA16042

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