A PHASE II TRIAL OF Hu3S193 THERAPY FOR PATIENTS WITH PLATINUM REFRACTORY OR PLATINUM RESISTANT EPITHELIAL OVARIAN, PRIMARY PERITONEAL AND 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 > 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 involvement by tumor
PATIENT CHARACTERISTICS:
Inclusion criteria:
- Karnofsky performance status > 70%
- Life expectancy ≥ 12 weeks
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Serum bilirubin ≤ 2.0 mg/dL
- AST and ALT ≤ 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 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