Monoclonal Antibody Therapy in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer
This trial is active, not recruiting.
|Conditions||fallopian tube cancer, ovarian cancer, primary peritoneal cavity cancer|
|Start date||November 1998|
|Trial size||102 participants|
|Trial identifier||NCT00004064, ALTAREX-OVA-Gy-10, CDR0000067265, OU-08111|
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Randomized phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have ovarian, fallopian tube, or peritoneal cancer.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Newport Beach, CA||Gynecologic Oncology Associates||no longer recruiting|
|Fort Myers, FL||Lee Memorial Health System||no longer recruiting|
|Orlando, FL||Walt Disney Memorial Cancer Institute||no longer recruiting|
|Tampa, FL||H. Lee Moffitt Cancer Center and Research Institute||no longer recruiting|
|Indianapolis, IN||Indiana University Cancer Center||no longer recruiting|
|Iowa City, IA||University of Iowa Hospitals and Clinics||no longer recruiting|
|Baltimore, MD||Mercy Medical Center, Inc.||no longer recruiting|
|Saint Louis, MO||Barnes-Jewish Hospital||no longer recruiting|
|Saint Louis, MO||St. John's Mercy Medical Center||no longer recruiting|
|Oklahoma City, OK||University of Oklahoma College of Medicine||no longer recruiting|
|Philadelphia, PA||Fox Chase Cancer Center||no longer recruiting|
|Columbia, SC||Palmetto Richland Memorial Hospital||no longer recruiting|
|Dallas, TX||Texas Oncology, P.A.||no longer recruiting|
|Charlottesville, VA||Cancer Center, University of Virginia HSC||no longer recruiting|
|Newport News, VA||Riverside Regional Medical Center||no longer recruiting|
|Ottawa, Canada||Ottawa Regional Cancer Center - General Division||no longer recruiting|
Female participants at least 18 years old.
DISEASE CHARACTERISTICS: Histologically proven epithelial adenocarcinoma of the ovary, fallopian tube, or peritoneum CA 125 greater than 35 U/mL No conclusive radiological or clinical evidence of disease No disease recurrence Must have received only 1 prior platinum based chemotherapy regimen No tumors of low malignant potential or noninvasive disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 6 months Hematopoietic: Hemoglobin at least 8.0 g/dL Lymphocyte count at least 1,000/mm3 Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal Renal: Creatinine no greater than 2 mg/dL Cardiovascular: No uncontrolled hypertension No congestive heart failure No arrhythmias Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active autoimmune disease requiring chronic treatment No allergy to murine proteins No documented anaphylactic reaction to any drug No active infection causing fever No immunodeficiency disease No uncontrolled nonmalignant diseases No other malignancy (except nonmelanomatous skin cancer or carcinoma in situ of the cervix) unless curatively treated and free of disease for at least 5 years PRIOR CONCURRENT THERAPY: Biologic therapy: No prior murine monoclonal antibodies Chemotherapy: See Disease Characteristics At least 4 weeks since prior platinum based chemotherapy No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 6 months since prior limited field (i.e., abdominal or pelvic) radiotherapy No prior whole abdominal radiotherapy Surgery: At least 4 weeks since prior surgery No prior splenectomy Other: At least 4 weeks since prior immunosuppressive drugs No concurrent immunosuppressive drugs At least 30 days since other prior investigational drugs
|Official title||A Randomized, Double-Blind, Placebo-Controlled, Phase IIB Study of the Safety and Efficacy of OVAREX MabB43.13 in Ovarian Cancer Patients With an Elevated Serum CA 125 But Without Other Evidence of Disease|
|Description||OBJECTIVES: I. Determine the safety of OvaRex monoclonal antibody B43.13 in patients with elevated CA 125 and histologically proven epithelial adenocarcinoma of the ovary, fallopian tube, or peritoneum, but without other evidence of disease. II. Determine the time to disease progression, overall survival, CA 125 levels, immune responses, and quality of life of these patients treated with this regimen. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms: Arm I: Patients receive placebo IV during weeks 1, 3, 5, 9, 13, 25, 37, and 49. Arm II: Patients receive OvaRex monoclonal antibody B43.13 (MOAB B43.13) IV during weeks 1, 3, 5, 9, 13, 25, 37, and 49. Patients in either treatment arm who have no disease progression after week 49 receive MOAB B43.13 once every 12 weeks until week 121. Patients with disease progression after week 49 may receive MOAB B43.13 alone, in combination with, or following chemotherapy. Quality of life is assessed during the study. PROJECTED ACCRUAL: A total of 102 patients will be accrued for this study.|
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