Consolidation Therapy With Hu3S193 for Women With Ovarian, Primary Peritoneal or Fallopian Tube Cancer
Condition: Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer
MeSH terms: Fallopian Tube Neoplasms
Intervention: Monoclonal antibody Hu3S193
Intervention description: 30 mg/m2 of Monoclonal antibody Hu3S193, IV as a single agent every two weeks, in a total of 12 doses (treatment period duration: 23 weeks). Anti-Lewis Y humanized monoclonal antibody designated "orphan drug" by the FDA on March 09, 2012 for the treatment of ovarian cancer, not yet approved for the orphan designation.
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      RATIONALE: Monoclonal antibodies, such as Hu3S193, can block tumor growth in different ways.
      Some block the ability of tumor cells to grow and spread. Others find tumor cells and help
      kill them or carry tumor-killing substances to them.

      PURPOSE: This phase II trial is studying how well Hu3S193 works as a consolidation therapy
      for women with relapsing platinum-sensitive ovarian, primary peritoneal or fallopian tube
      cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The Informed Consent Form (ICF) must be signed before the performance of any study
             specific procedure or treatment.

          2. Female patients of >= 18 years of age.

          3. Relapsing ovarian adenocarcinoma, fallopian tubes or primary peritoneal who achieved a
             complete clinical response after the first treatment of relapse with platinum-based
             regimen. A complete response is defined as the absence of cancer related symptoms,
             normal physical exam, normal CA-125 (tumor marker) level, normal chest X-ray and
             CT-scan of abdomen/pelvis. Eligibility allows the presence of nonspecific findings as
             long as not showing clear evidence of disease such as: lymph node and/or soft tissue
             abnormalities <= 1.0 cm which are frequently present on the pelvis and will not be
             considered to be a conclusive evidence of disease.

          4. Expression of antigen Ley documented by immunohistochemistry of archived primary or
             metastatic tumor samples.

          5. The patient must have been submitted at least to hysterectomy and bilateral
             salpingo-oophorectomy before entering the study and must have received platinum-based
             chemotherapy as adjunctive or neo-adjunctive treatment at the first presentation.

          6. At least 5 and no more than 8 cycles of platinum combination therapy (i.e. doublet) as
             treatment for the first relapse.

          7. All side effects from chemotherapy must have been resolved or must be grade 1.

          8. Interval between the last dose of the treatment with platinum that achieved clinical
             CR (complete response) and the first dose of Hu3S193 =< 8 weeks.

          9. Karnofsky performance status >= 70%.

         10. Results of laboratorial exams in the first 2 weeks before drug infusion within the
             following values:

               -  Absolute Neutrophil Count >= 1.5 x 10x3 / mm3

               -  Platelet count >= 100 x 10x3 / mm3

               -  Blood bilirubin <= 2.0 mg/dL

               -  Aspartate aminotransaminase (AST) and Alanine aminotransferase (ALT) <= 2.5 x
                  upper limit of normal (ULN).

               -  Blood creatinine <= 2.0 mg/dL.

               -  Prothrombin time < 1.3 x control

         11. Expected survival >= 12 months.

         12. Patients must be willing to participate and be able to comply with the protocol
             throughout the study.

        Exclusion Criteria:

          1. Mucinous or clear cell histology.

          2. Patients must not have received Bevacizumab as part of their treatment on relapse.

          3. Diagnosis of primary tumor relapse made exclusively based on elevated levels of serum
             CA-125 with values <2-fold the upper limit of normality.

          4. Concomitant use of systemic corticosteroids or immunosuppressive agents.

          5. Known CNS (central nervous system) involvement by tumor.

          6. Clinically significant heart disease (New York Heart Association Class III or IV).

          7. ECG indicating clinically significant arrhythmia.

          8. History of myocardial infarction within 6 months.

          9. Other serious diseases, (e.g.: serious infections requiring antibiotics, bleeding
             disorders, chronic inflammatory bowel disease, or diseases that may interfere in the
             obtainment of accurate study results).

         10. Radiotherapy treatment, radiopharmaceuticals (e.g. 32P), biological therapy,
             anti-estrogen therapy (including tamoxifen), immunotherapy or surgery within 4 weeks
             before the first administration of investigational product fail to recover from toxic
             effects of any of these therapies within 6 weeks prior to study inclusion.

         11. Exposure to any investigational product within 4 months prior to study inclusion.

         12. Previous treatment with a humanized murine antibody and/or fragment of such antibody.

         13. Previous history of tumor (excluding appropriately treated non-melanoma skin cancer or
             carcinoma in situ of the cervix or no evidence of disease within at least 5 years for
             previous breast cancer or stage I endometrial cancer).