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A Double-Blind Placebo Controlled Trial of Intravenous OvaRex MAb-B43.13 as Post Chemotherapy Consolidation for Ovarian Tubal and Peritoneal Carcinoma


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

A Double-Blind Placebo Controlled Trial of Intravenous OvaRex MAb-B43.13 as Post Chemotherapy Consolidation for Ovarian Tubal and Peritoneal Carcinoma


OBJECTIVES: I. Compare the time to disease relapse, survival, and quality of life of
patients with stage III or IV ovarian epithelial, tubal, or peritoneal adenocarcinoma
treated with OvaRex monoclonal antibody B43.13 OR placebo following complete clinical
response to primary therapy. II. Determine the safety of this regimen in these patients.
III. Assess the immune response of patients treated with this regimen.

OUTLINE: This is a randomized study. Patients undergo a laparotomy and platinum based
chemotherapy prior to randomization. Patients are randomized to 1 of 2 treatment arms: Arm
I: Patients receive OvaRex monoclonal antibody B43.13 IV on day 0. Treatment continues at 4,
8, 20, 32, 44, and 56 weeks, and then every 3 months in the absence of disease progression
or unacceptable toxicity. Arm II: Patients receive placebo IV on day 0. Placebo
administration continues on the same schedule as in arm I. Patients presenting with relapse
are provided with second line chemotherapy. Quality of life is assessed at the beginning of
the study, after 2 months, and then every 3 months thereafter. Patients are followed every 3
months.

PROJECTED ACCRUAL: A total of 400 patients (200 per arm) will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven stage III or IV ovarian epithelial, tubal,
or peritoneal adenocarcinoma Must have had complete clinical response to primary therapy
consisting of surgical debulking and platinum based chemotherapy Elevated CA 125 (greater
than 35 U/mL) prior to or at surgery (if presurgical CA 125 measurement is not available,
patient must have a serum CA 125 of at least 100 U/mL and strong tumor tissue expression)
Must have residual disease (visible or palpable) at completion of the staging laparotomy
(IIIB and IIIC microscopic disease)

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Karnofsky 60-100%
Life expectancy: At least 6 months Hematopoietic: Hemoglobin at least 8.0 g/dL Lymphocyte
count at least 300/mm3 Neutrophil count at least 1,000/mm3 Platelet count at least
100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal Renal:
Creatinine no greater than 1.6 mg/dL

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 weeks since prior immunotherapy No
prior murine monoclonal antibodies for diagnostic or therapeutic purposes Chemotherapy: No
more than 1 prior regimen of chemotherapy (change in chemotherapy agents is permitted
during primary therapy provided that the change is considered to be part of initial
chemotherapy regimen) At least 4 weeks since prior chemotherapy Endocrine therapy: Not
specified Radiotherapy: At least 4 weeks since prior abdominal, abdominopelvic, or pelvic
radiotherapy Surgery: At least 4 weeks since prior surgery No more than 1 interval
debulking procedure

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Jonathan S. Berek, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066718

NCT ID:

NCT00003634

Start Date:

April 1998

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • fallopian tube cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
Chao Family Comprehensive Cancer CenterOrange, California  92868
University of Colorado Cancer CenterDenver, Colorado  80262
University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
Cancer Center, University of Virginia HSCCharlottesville, Virginia  22908
Marlene & Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
New England Medical Center HospitalBoston, Massachusetts  02111
Baptist Regional Cancer Center - KnoxvilleKnoxville, Tennessee  37901
Henry Ford HospitalDetroit, Michigan  48202
University of Minnesota Medical SchoolMinneapolis, Minnesota  55455
Lutheran General Cancer Care CenterPark Ridge, Illinois  60068
North Shore University HospitalManhasset, New York  11030
Swedish Hospital Tumor InstituteSeattle, Washington  98104
University of Texas Southwestern Medical SchoolDallas, Texas  75235-9032
Walt Disney Memorial Cancer InstituteOrlando, Florida  32803
Alta Bates Comprehensive Cancer CenterBerkeley, California  94704
University of Florida Health Science Center - JacksonvilleJacksonville, Florida  32209
Wilshire Oncology Medical CenterPomona, California  91767
Stanford University School of MedicineStanford, California  94305-5317
Patty Berg Cancer CenterFort Myers, Florida  33901
Saint Mary's HospitalEast Saint Louis, Illinois  62201
Alton Ochsner Medical Foundation HospitalNew Orleans, Louisiana  70121
Ellis Fischel Cancer CenterColumbia, Missouri  65203
University of OklahomaOklahoma City, Oklahoma  73190
Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
U.S. OncologyHouston, Texas  77060