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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


Phase 3
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer

Thank you

Trial Information

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


This a Phase III, double-blind, placebo-controlled, multi-center study of intravenous
OvaRex® MAb-B43.13 as post-chemotherapy consolidation for epithelial carcinoma of ovarian,
tubal, or peritoneal origin.


Inclusion Criteria:



- Patients must have a histological diagnosis of epithelial adenocarcinoma of ovarian,
tubal or peritoneal origin, and their disease is classified as FIGO Stage III or IV.
Histological diagnosis must have been confirmed by site pathology review of slides as
documented by the site investigator. These slides must be made available for sponsor
review.

- Patients must have had an elevated serum CA125 level (per reference lab normal range)
measured prior to or at surgery (i.e., not later than the immediate post-surgery
period when the patient is in the surgical recovery room). If a pre-surgical CA125
measurement is not available, then the patient must have had: (a) a serum CA125 level
≥100 U/mL, and (b) tumor tissue that has been demonstrated by immunohistochemical
methods to express CA125.

- Patients must have had a documented serum CA125 level ≤65 U/mL prior to the third
cycle of front-line chemotherapy.

- Patients must have had microscopic or small diameter residual disease following
primary de-bulking surgical procedure.

- Patients must have received chemotherapy that included a platinum compound and a
taxane following appropriate staging procedures. Front-line treatment can include no
more than 8 cycles of chemotherapy.

- Patients must have had a complete clinical response to their front-line surgery and
chemotherapy. A complete clinical response is defined as one in which the patient
had a normal physical examination, no conclusive evidence of residual tumor by CT of
the abdomen and pelvis, a normal chest x-ray, and a serum CA125 level at least 5 U/mL
but less than 35 U/mL as measured in the pretreatment baseline laboratories by the
protocol Central Lab.

- Patients must have undergone no more than one interval de-bulking procedure.

- Patients must receive their first dose of study medication between 4 and 12 weeks
after completing their last dose of front-line chemotherapy.

- Patients must have voluntarily agreed to participate and have signed the informed
consent, and are willing to complete all study procedures.

Exclusion Criteria:

- Patients who have received more than one prior regimen of chemotherapy. A change in
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.

- Patients with known refractory or recurrent epithelial adenocarcinoma of ovarian,
tubal, or peritoneal origin requiring chemotherapy.

- Patients who have compromised hematopoietic function (hemoglobin <8.0 g/dL;
lymphocyte count <300 mm³; neutrophil count <1000 mm³; platelet count <100,000 mm³.

- Patients with hepatic dysfunction defined as a bilirubin >1.5 times the upper normal
limits, LDH, SGOT and SGPT>2 times upper limits of normal or albumin <3.5 g/dL.

- Patients with severe renal dysfunction defined as a serum creatinine >1.6 mg/dL.

- Patients with a known allergy to murine proteins or have had a documented
anaphylactic reaction to any drug, or a known hypersensitivity to diphenhydramine or
other antihistamines of similar chemical structure.

- Patients who have contraindications to the use of pressor agents.

- Patients being chronically treated with immunosuppressive drugs such as cyclosporin,
ACTH, or systemic corticosteroids.

- Patients who have received immunotherapy (interferons, tumor necrosis factor, other
cytokines [e.g., interleukins] or biological response modifiers, or BCG vaccines)
within 6 weeks of receiving their first dose of study medication. Patients who have
received hemopoietic factors are acceptable.

- Patients who have had a splenectomy.

- Patients with uncontrolled diseases other than cancer will be excluded. Patients
with chronic diseases that are well controlled (e.g., diabetes mellitus,
hypertension) are eligible.

- Patients who have a concurrent illness or chronically taking medication, which would
confound the results of the study, preclude the patient from completing the study, or
mask an adverse reaction.

- Patients who have a concurrent malignancy (except non-melanoma of the skin, in situ
carcinoma of cervix), unless the patient received curative treatment and has been
disease free for greater than or equal to 5 years.

- Patients receiving other investigational drugs within 30 days of enrollment.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

OVA-Gy-17

NCT ID:

NCT00050375

Start Date:

December 2002

Completion Date:

December 2007

Related Keywords:

  • Ovarian Cancer
  • OvaRex
  • ovarian
  • CA125
  • murine
  • antibody
  • immunotherapy
  • Ovarian Neoplasms

Name

Location

UCLA School of MedicineLos Angeles, California  900121973
Stanford UniversityStanford, California  94305
Cedars-Sinai Medical CenterLos Angeles, California  90048
North Shore University HospitalManhasset, New York  11030
Florida Hospital Cancer InstituteOrlando, Florida  32804
Southwest Regional Cancer CenterAustin, Texas  78705
Comprehensive Cancer InstituteHuntsville, Alabama  35801
Arlington Cancer CenterArlington, Texas  76012
University of Virginia Cancer CenterCharlottesville, Virginia  22908
Magee-Womens HospitalPittsburgh, Pennsylvania  15213-3180
Medical College of Ohio Cancer InstituteToledo, Ohio  43614
Ellis Fischel Cancer CenterColumbia, Missouri  65203
Sharp Memorial HospitalSan Diego, California  92123
Medical College of GeorgiaAugusta, Georgia  30912
Gynecologic Oncology AssociatesNewport Beach, California  92663
Cancer Care NorthwestSpokane, Washington  99202
St. Vincent's Comprehensive Cancer CenterNew York, New York  10011
Duke University Medical CenterDurham, North Carolina  27710
South Carolina Oncology AssociatesColumbia, South Carolina  29201
Swedish Medical CenterSeattle, Washington  98122-4307
Nyack HospitalNyack, New York  10960
Blumenthal Cancer CenterCharlotte, North Carolina  28203
New England Medical CenterBoston, Massachusetts  
Texas OncologyDallas, Texas  
Wilshire Oncology Medical GroupGlendora, California  91741
Western Regional Community Clinical Oncology ProgramPhoenix, Arizona  85006
Little Rock Hematology Oncology Assoc.Little Rock, Arkansas  72205
St. Jude Medical CenterFullerton, California  92835
University of California, IrvineOrange, California  92868
Rocky Mountain Cancer Center-MidtownDenver, Colorado  80218
University of Connecticut Cancer CenterFarmington, Connecticut  06030
Northwestern Connecticut Oncology Hematology Associates, LLPTorrington, Connecticut  06790
Florida Gynecologic OncologyFort Myers, Florida  33901
Pensacola Research ConsultantsPensacola, Florida  32504
H. Lee Moffitt Cancer Center and ResearchTampa, Florida  33612-9497
The University of Chicago HospitalsChicago, Illinois  60637
St. Vincent Gynecologic OncologyIndianapolis, Indiana  46260
Michiana Hematology Oncology PCSouth Bend, Indiana  46617
Louisville OncologyLouisville, Kentucky  40202
Brown Cancer CenterLouisville, Kentucky  40202
Lake Charles Medical Surgical ClinicLake Charles, Louisiana  70601
Hematology and Oncology SpecialistsNew Orleans, Louisiana  70115
The Harry and Jeanette Weinberg Cancer InstituteBaltimore, Maryland  21237-3998
Women's Specialty CenterJackson, Mississippi  39202
Jersey Shore Medical CenterNeptune, New Jersey  07754
SUNY-HSC Syracuse, Crouse HospitalSyracuse, New York  13210
University Hospital - Health SystemsCleveland, Ohio  44106
GYN Oncology and Pelvic Surgery AssociatesColumbus, Ohio  43222
ProMedica Health SystemsToledo, Ohio  43606
Oklahoma University Health Sciences CenterOklahoma City, Oklahoma  73104
Northwest Cancer Specialists-NorthrupPortland, Oregon  97210
Brown University School of MedicineProvidence, Rhode Island  02905
Gynecologic Oncology Research and DevelopmentGreenville, South Carolina  29601
Chattanooga GYN OncologyChattanooga, Tennessee  37403
West Clinic, PCMemphis, Tennessee  38120
Univ. of Texas SW Medical Center at DallasDallas, Texas  75235-9032
Texas Oncology, PADallas, Texas  75246-2006
The Center for Cancer and Blood DisordersFort Worth, Texas  76104
Utah Cancer SpecialistsSalt Lake City, Utah  84106
VA Oncology AssociatesNorfolk, Virginia  23502
Carilion GYN Oncology AssociatesRoanoke, Virginia  24014
Northwest Cancer Specialists-VancouverVancouver, Washington  98684