Hu3S193 in Treating Women With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

Inclusion 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:
• •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