Clinical Drug Experience Knowledgebase

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