Effectiveness of MORAb-003 in Women With Ovarian Cancer Who Have Relapsed After Platinum-Based Chemotherapy
Condition: Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Neoplasms
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms; Peritoneal Neoplasms
Intervention: Farletuzumab; Chemo Plus Far
Intervention description: Weekly Farletuzumab infusions Dose dependent on dosing group; Chemo+Far: paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle plus farletuzumab, 100 mg/m2.
Intervention MeSH terms: Farletuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ovarian Cancer; Primary Fallopian Tube Cancer; Peritoneal Cancer

Summary:

      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.
    

Eligibility 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.