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Effectiveness of MORAb-003 in Women With Ovarian Cancer Who Have Relapsed After Platinum-Based Chemotherapy
This study is ongoing, but not recruiting participants.
Sponsored by: Morphotek
Information provided by: Morphotek
ClinicalTrials.gov Identifier: NCT00318370
  Purpose

The purpose of this study is to determine if an investigational drug called MORAb-003 is useful by itself or when used with other approved cancer drugs in treating women with ovarian cancer. MORAb-003 is a monoclonal antibody directed against an antigen on most ovarian cancers.


Condition Intervention Phase
Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Neoplasms
Drug: MORAb-003
Phase II

MedlinePlus related topics: Cancer Ovarian Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: A Study of the Efficacy of MORAb-003 in Subjects With Platinum-Sensitive Epithelial Ovarian Cancer in First Relapse

Further study details as provided by Morphotek:

Primary Outcome Measures:
  • Change in CA125 level
  • Overall response rate by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
  • Progression free survival
  • Prolongation of response
  • Disease-free survival
  • Overall survival

Secondary Outcome Measures:
  • Safety
  • Pharmacokinetics

Estimated Enrollment: 60
Study Start Date: May 2006
Estimated Study Completion Date: February 2009
Detailed Description:

MORAb-003 is a monoclonal antibody that has the potential to be an effective agent against epithelial ovarian cancer (including primary fallopian tube and peritoneal adenocarcinoma) either alone or in combination with other drugs. MORAb-003 works by a different mechanism from other cancer therapeutics and has been shown to be well tolerated. This study allows the opportunity to determine if MORAb-003 can work either as a single agent

  1. to treat a CA125-only relapse, or
  2. in combination with standard platinum and taxane chemotherapy to treat a symptomatic relapse, and
  3. to prolong a second response to chemotherapy.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female subjects at least 18 years of age, with a histologically confirmed diagnosis of non-mucinous epithelial ovarian cancer (including fallopian tube and primary peritoneal cancer) in first relapse after a first remission of 6 to 18 months duration.
  • Subjects must have undergone surgery. Subjects must have received primary chemotherapy, including at least one platinum agent.
  • Subject is eligible for retreatment with the same chemotherapy regimen that was used to induce remission (Exception: may reduce the dose of or discontinue taxane if contraindicated due to neurotoxicity.)
  • CA125 must have been elevated prior to original chemotherapy.
  • CA125 must be elevated at the time of relapse.
  • Life expectancy greater than or equal to 6 months, as estimated by the investigator.
  • Eastern Cooperative Oncology Group performance status of 0, 1 or 2
  • Subjects must consent to use a medically acceptable method of contraception throughout the study period and for 28 days after final MORAb-003 administration, unless surgically sterile.
  • Any significant concomitant medical conditions must be well controlled and stable in the opinion of the investigator for at least 30 days prior to Study Day 1.
  • Laboratory and clinical results within the 2 weeks prior to Study Day 1 as follows:

    • Absolute neutrophil count (ANC) ≥ 1.2 x 10e9/L
    • Platelet count ≥ 100 x 10e9/L
    • Hemoglobin ≥ 8 g/dL
  • Subject must be willing and able to provide written informed consent. Translations of informed consent information may be provided, subject to the local institutional review board's (IRB's) policy.

Exclusion Criteria:

  • Known central nervous system (CNS) tumor involvement.
  • Evidence of other active malignancy requiring treatment.
  • Clinically significant heart disease (e.g., congestive heart failure of New York Heart Association Class III or IV, angina not well controlled by medication, or myocardial infarction within 6 months).
  • Electrocardiogram (ECG) demonstrating clinically significant arrhythmias (Exception: Subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia [SVT], are eligible).
  • Active serious systemic disease, including active bacterial or fungal infection.
  • Active hepatitis or HIV infection.
  • Treatment within three months with immunomodulatory therapy (e.g. interferons, immunoglobulin therapy, interleukin 1 receptor antagonist [IL-1RA] or systemic corticosteroids). Short term systemic corticosteroids or topical or intra-articular steroids are acceptable, subject to the judgment of the investigator.
  • Treatment with a monoclonal antibody therapy AND have evidence of an immune or allergic reaction or documented HAHA.
  • Maintenance of first remission by taxane or other chemotherapeutic agent(s).
  • Initiation or planned initiation of cancer therapy not given to induce primary remission. Substitutions of agents materially similar to those used in the original regimen are permissible.
  • Breast-feeding, pregnant, or likely to become pregnant during the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00318370

Locations
United States, California
Sharp HealthCare
San Diego, California, United States, 92123
United States, Indiana
St. Vincent Gynecologic Oncology
Indianapolis, Indiana, United States, 46260
United States, Louisiana
Jayne Gurtler, M.D.
Metairie, Louisiana, United States, 70006
Hematology and Oncology Specialists, LLC
Metarie, Louisiana, United States, 70006
Hematology and Oncology Specialists, LLC
Covington, Louisiana, United States, 70433
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21231
United States, New Jersey
The Center for Cancer and Hematologic Disease
Cherry Hill, New Jersey, United States, 08003
The Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Cooper University Hospital
Voorhees, New Jersey, United States, 08043
United States, New York
New York Oncology Hematology
Albany, New York, United States, 12206
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
United States, Pennsylvania
Lehigh Valley Women's Cancer Center
Allentown, Pennsylvania, United States, 18104
United States, South Carolina
Gynecology Oncology Research & Development
Greenville, South Carolina, United States, 29601
United States, Texas
Mary Crowley Medical Research Center
Dallas, Texas, United States, 75246
South Texas Oncology & Hematology
San Antonio, Texas, United States, 78229
Tyler Cancer Center
Tyler, Texas, United States, 75702
United States, Virginia
Northern Virginia Pelvic Surgery Associates
Annandale, Virginia, United States, 22003
Peninsula Cancer Center
Newport News, Virginia, United States, 23601
Germany
Nationales Centrum fur Tumorerkrankungen
Heidelberg, Germany
Krankenhaus Nordwest
Frankfurt, Germany
Sponsors and Collaborators
Morphotek
Investigators
Study Director: Martin D. Phillips, M.D. Morphotek, Inc.
  More Information

Study ID Numbers: MORAb-003-002
Study First Received: April 24, 2006
Last Updated: January 9, 2009
ClinicalTrials.gov Identifier: NCT00318370  
Health Authority: United States: Food and Drug Administration

Keywords provided by Morphotek:
Ovarian Cancer
Primary Fallopian Tube Cancer
Peritoneal Cancer

Study placed in the following topic categories:
Ovarian cancer
Ovarian Neoplasms
Digestive System Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Ovarian epithelial cancer
Abdominal Neoplasms
Fallopian Tube Neoplasms
Fallopian Tube Diseases
Genital Diseases, Female
Digestive System Diseases
Peritoneal Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Fallopian tube cancer
Peritoneal Neoplasms
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Adnexal Diseases

ClinicalTrials.gov processed this record on January 13, 2009