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An Open-Label, Phase II Study of Ovarex® MAb-B43.13 as an Adjuvant Treatment to Platinum-Based Front-Line Chemotherapy of Advanced Epithelial Carcinoma of Ovarian, Tubal, or Peritoneal Origin

Phase 2
80 Years
Not Enrolling
Ovarian Cancer

Thank you

Trial Information

An Open-Label, Phase II Study of Ovarex® MAb-B43.13 as an Adjuvant Treatment to Platinum-Based Front-Line Chemotherapy of Advanced Epithelial Carcinoma of Ovarian, Tubal, or Peritoneal Origin

Inclusion Criteria:

- A histologic diagnosis of primary peritoneal carcinoma or epithelial ovarian
carcinoma, Stage III - IV, expressing the tumor-associated antigen CA125 as measured
by a serum CA125 level ≥ 35 U/mL and tumor tissue which has been demonstrated by
immunohistochemical methods to express CA125. All patients must provide primary tumor
(and lymph node and ascites samples, if available) samples for cellular immunology
assays and characterization

- A functional performance status of ≤2 on the ECOG scale

- Are randomized into the study no more than eight (8) weeks postoperatively

- Have an expected survival of at least 6 months

- Age less than or equal to 80 years of age

- Be willing and able to comply with the protocol for the duration of the study

- Have given written informed consent, prior to any study-related procedure not part of
normal medical care, with the understanding that consent may be withdrawn by the
patient at any time without prejudice to their future medical care

Exclusion Criteria:

- Have received radiotherapy or chemotherapy

- Have circumstances at the time of entry onto the protocol would not permit completion
of study or require follow-up

- Have other invasive malignancies, with the exception of non-melanoma skin cancer and
carcinoma in situ of the cervix, who had (or have) any evidence of the other cancer
present within the last 5 years or whose previous cancer treatment contraindicates
this protocol therapy

- Have significant cardiovascular abnormalities [uncontrolled hypertension, Congestive
Heart Failure (CHF) New York Heart Association (NYHA) Classes II-IV, see Appendix C),
uncontrolled angina, myocardial infarction within the past six months or uncontrolled
arrhythmias]. Patients with evidence of abnormal cardiac conduction (e.g. bundle
branch block, heart block) are eligible if their disease has been stable for the past
six months

- Have an active autoimmune disease (e.g., rheumatoid arthritis, Systemic Lupus
Erythematosus (SLE), ulcerative colitis, Crohn's Disease, MS, ankylosing spondylitis)
requiring active immunosuppressive therapy

- Have a known allergy to murine proteins or have had a documented anaphylactic
reaction to any drug

- Are being chronically treated with immunosuppressive drugs such as cyclosporin,
Adrenocorticotrophic Hormone (ACTH), or systemic corticosteroids

- Have a recognized immunodeficiency disease including cellular immunodeficiencies,
hypogammaglobulinemia or dysgammaglobulinemia; patients who have acquired,
hereditary, congenital immunodeficiencies, Human Immunodeficiency Virus, or status
post splenectomy

- Have an uncontrolled disease (e.g. deteriorating renal function or nephropathy,
active hepatitis, etc.) other than cancer. Patients with chronic diseases that are
well controlled (e.g., diabetes mellitus, hypertension) are eligible

- Are taking mono-amine oxidase inhibitors or who have other contraindications to the
use of pressor agents (e.g. epinephrine)

- Are unable to read or understand, and/or unwilling to sign a written consent form
which must be obtained prior to surgery and prior to treatment Surgery

- Patients will not be required to undergo second-look surgery (such surgery will be at
the option of the investigator)

- If patients undergo a second surgical procedure for a clinically indicated
circumstance, an interval tumor sample with ascites and lymph node (if available)
should be obtained, if present, for immunological evaluation and provided to the
study tissue bank

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


United States: Food and Drug Administration

Study ID:




Start Date:

July 2004

Completion Date:

December 2007

Related Keywords:

  • Ovarian Cancer
  • oregovomab
  • ovarex
  • ovarian cancer
  • ovary
  • ovarian carcinoma
  • front-line
  • Ovarian Neoplasms