Effectiveness of MORAb-003 in Women With Ovarian Cancer Who Have Relapsed After Platinum-Based Chemotherapy

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.