Hu3S193 in Treating Women With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
Condition: Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cancer
MeSH terms: Fallopian Tube Neoplasms
Intervention: hu3S193
Intervention description: 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent ovarian epithelial cancer; recurrent fallopian tube cancer; recurrent primary peritoneal cancer

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 in treating patients with
      ovarian epithelial cancer, fallopian tube cancer, or peritoneal cavity cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal
             carcinoma

               -  Progressive disease

               -  Disease must express Lewis-Y antigen documented by immunohistochemistry in
                  archived or fresh primary or metastatic tumor biopsies

          -  Measurable disease, including at least one measurable lesion, according to RECIST
             criteria or CA-125 (Cancer Antigen-125) > 2 times upper normal limit

               -  Pleural effusion, ascites, bone metastases, and lesions located in previously
                  irradiated areas are not considered measurable

          -  Disease must be considered platinum-refractory or resistant, meeting any of the
             following criteria:

               -  Platinum-refractory defined as progression during the initial platinum-based
                  chemotherapy regimen or failure to achieve a complete response (e.g., stable
                  disease or partial response) with evidence of progressive disease (by physical
                  examination, radiological exams, or CA-125) during the initial platinum-based
                  chemotherapy

               -  Platinum-resistant defined as recurrence within six months of completion of the
                  initial platinum-based regimen (primary platinum-resistance) or recurrence after
                  six months of completion of the initial platinum-based regimen (still considered
                  platinum-sensitive, but incurable by any approach, that will progress to a
                  secondary platinum-resistance scenario) and failure to ≥ 1 re-induction with a
                  platinum-based regimen (secondary platinum-resistance)

          -  No high tumor burden, as assessed by the investigator

          -  No rapidly progressing disease, as assessed by clinical evaluation

          -  No known CNS (Central Nervous System) involvement by tumor

        PATIENT CHARACTERISTICS:

        Inclusion criteria:

          -  Karnofsky performance status > 70%

          -  Life expectancy ≥ 12 weeks

          -  ANC (absolute neutrophil count) ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Serum bilirubin ≤ 2.0 mg/dL

          -  AST (aspartate aminotransferase) and ALT (alanine aminotransferase) ≤ 2.5 times upper
             limit of normal (ULN) (≤ 5 times ULN if with liver metastases)

          -  Creatinine ≤ 2.0 mg/dL

          -  Prothrombin time < 1.3 times control

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

        Exclusion criteria:

          -  NYHA (New York Heart Association) class III or IV heart disease

          -  Clinically significant arrhythmias by ECG

          -  Myocardial infarction within the past 6 months

          -  Any other serious illness, including any of the following:

               -  Severe ascites

               -  Severe active infections requiring antibiotics

               -  Bleeding disorders

               -  Chronic inflammatory bowel disease

               -  Diseases that might interfere with the collection of accurate results from this
                  study

          -  Positive for human anti-human antibodies

          -  Prior history of tumor (excluding adequately treated nonmelanoma skin cancer or
             carcinoma in situ of the uterine cervix)

          -  Uncontrolled hypercalcemia (i.e., > 11.5 mg/dL)

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  Recovered from the toxic effects of any prior therapy

          -  No concurrent systemic steroids or immunosuppressant agents

          -  No more than 1 prior non-platinum-containing regimen for the treatment of
             platinum-resistant/refractory disease

               -  Patients who receive 2 or more different non-platinum-containing chemotherapy
                  regimens for platinum-resistant/refractory disease are not eligible

          -  More than 4 weeks since prior and no other concurrent chemotherapy, radiotherapy,
             radiopharmaceuticals (e.g., ^32P), biological therapy, anti-estrogen therapy
             (including tamoxifen), immunotherapy, or surgery

          -  More than12 weeks since prior investigational agent

          -  No prior treatment with a murine or humanized antibody and/or antibody fragment