Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 12:04 AM
NCT ID:
NCT00005858
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed advanced colon, breast, non-small cell lung, bladder, pancreas, or ovarian cancer refractory to standard treatment or for which no effective standard therapy exists
* Expresses Lewis Y antigen
* Evidence of disease progression
* B3 antigen on the surface of more than 30% of the tumor cells determined by immunohistochemistry
* No neutralizing antibodies to LMB-9 immunotoxin
* No untreated CNS metastases
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Sex:
* Male or female
Performance status:
* ECOG 0-1
Life expectancy:
* At least 3 months
Hematopoietic:
* Absolute granulocyte count greater than 1,200/mm\^3
* Platelet count greater than 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 times normal
* SGOT and SGPT no greater than 2.5 times upper limit of normal (liver metastases allowed)
* Albumin at least 3.0 g/dL
* No prior liver disease (e.g., alcohol liver disease)
* Hepatitis B and C negative
Renal:
* Creatinine no greater than 1.4 mg/dL
* Creatinine clearance greater than 60 mL/min
* Proteinuria less than 1 g/24 hours
Cardiovascular:
* No history of coronary artery disease
* No cardiac arrhythmia requiring therapy
* No New York Heart Association class II-IV congestive heart failure
Pulmonary:
* Pulmonary function test required if significant smoking history, possible pulmonary disease, or lung cancer
* FEV1 and FVC at least 65% predicted
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No known seizure disorders
* No urinary tract infection
* No other concurrent malignancy
* No active peptic ulcer disease
* No known allergy to omeprazole
* No contraindication to pressor therapy
* No other concurrent medical or psychological condition that would preclude study
PRIOR CONCURRENT THERAPY:
Chemotherapy:
* At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered
Endocrine therapy:
* At least 3 weeks since prior hormonal therapy
Radiotherapy:
* At least 3 weeks since prior radiotherapy and recovered
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00005858
Study Brief:
Protocol Section:
NCT00005858