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:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT00004856
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed transitional cell carcinoma (TCC) of the urothelium, including the bladder, urethra, ureter, or renal pelvis
* No pure adenocarcinomas, pure squamous cell carcinomas, small cell carcinoma, or only small foci of TCC (less than 10% of tumor specimen)
* Locally advanced (T4b) TCC of the bladder
* Metastatic (N2 or N3 or M1)TCC of the urothelium
* HER2 expression (3+) as determined by immunohistochemistry or gene amplification by fluorescent in situ hybridization
* Must not be a candidate for potentially curative surgery or radiotherapy
* Measurable disease
* At least 1 unidimensionally measurable lesion of at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
* The following lesions are considered nonmeasurable:
* Bone lesions
* Leptomeningeal disease
* Ascites
* Pleural/pericardial effusion
* Lymphangitis cutis/pulmonis
* Abdominal masses not confirmed and followed by imaging techniques
* Cystic lesions
* Primary bladder masses
* Relapsed from or failed to achieve a complete or partial response after 1 prior systemic chemotherapy regimen for TCC, including cisplatin, carboplatin, paclitaxel, docetaxel, or gemcitabine
* Prior adjuvant or neoadjuvant chemotherapy is considered 1 prior chemotherapy regimen
* Prior single-agent chemotherapy as a radiosensitizer is not considered a prior systemic chemotherapy regimen
* No known brain metastases
* Performance status - CTC 0-2
* More than 12 weeks
* Absolute neutrophil count at least 1,000/mm\^3
* Platelet count at least 75,000/mm\^3
* Bilirubin no greater than 2 times upper limit of normal (ULN)
* AST no greater than 2 times ULN
* Creatinine clearance at least 30 mL/min
* Ejection fraction at least 50% (or lower limit of normal) by echocardiogram or MUGA
* No history of ongoing congestive heart failure
* No active cardiac ischemia
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* HIV negative
* No known autoimmune disease
* No prior trastuzumab (Herceptin)
* At least 14 days since prior radiotherapy
* At least 30 days since prior chemotherapy
* Prior doxorubicin allowed provided cumulative dose is no greater than 300 mg/m\^2
* Prior epirubicin allowed provided cumulative dose is no greater than 600 mg/m\^2
* No concurrent chemotherapy
* No concurrent hormonal therapy except:
* Steroids given for adrenal failure
* Hormones administered for nondisease-related conditions (e.g., insulin for diabetes)
* Intermittent dexamethasone as an antiemetic or for sensitivity reactions to study drug
* No concurrent palliative radiotherapy
* Prior radiotherapy allowed provided treated area is not only site of measurable disease
* At least 14 days since prior surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00004856
Study Brief:
Protocol Section:
NCT00004856